Acetylcysteine (Page 4 of 4)

HOW SUPPLIED

Acetylcysteine Solution, USP is available in rubber stoppered glass vials containing 4, 10, or 30 mL. The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. The 10% solution may be used undiluted.

Acetylcysteine is sterile, not for injection and can be used for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). It is available as follows:

Acetylcysteine 10% solution (100 mg acetylcysteine per mL). Sterile, not for injection.

Product No.

NDC No.

Strength

695104 63323-695-04 10% (100 mg/mL) 4 mL 5 mL vials packed in carton of twenty five
693110 63323-693-10 10% (100 mg/mL) 10 mL 10 mL vials packed in carton of three, plastic dropper
691130 63323-691-30 10% (100 mg/mL) 30 mL 30 mL vials packed in carton of three

Acetylcysteine 20% solution (200 mg acetylcysteine per mL). Sterile, not for injection.

Product No.

NDC No.

Strength

694104 63323-694-04 20% (200 mg/mL) 4 mL 5 mL vials packed in carton of twenty five
692110 63323-692-10 20% (200 mg/mL) 10 mL 10 mL vials packed in carton of three, plastic dropper
690130 63323-690-30 20% (200 mg/mL) 30 mL 30 mL vials packed in carton of three

STORAGE:

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (see USP Controlled Room Temperature). Store in refrigerator 2° — 8°C (36° — 46°F) after opening.

Acetylcysteine does not contain an antimicrobial agent, and care must be taken to minimize contamination of the sterile solution. Dilutions of acetylcysteine should be used freshly prepared and utilized within one hour. If only a portion of the solution in a vial is used, store the remaining undiluted portion in a refrigerator and use within 96 hours.

REFERENCES:

  1. Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis , 1981; 61 (Suppl III): 45-51.

  2. Am Rev Respir Dis , 1960; 82:627−639.

Manufactured For:

fk logo
Fresenius Kabi USA, LLC
Lake Zurich , IL 60047
451291B

Revised: September 2018

Made in India

Code: AP/DRUGS/103/97

PRINCIPAL DISPLAY PANEL — 4 mL (20%) carton

NDC 63323- 694 -04 694104


ACETYLCYSTEINE
SOLUTION, USP

20% (200 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

25 x 4 mL Vials Rx only

ace42961A
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 mL (20%) container

NDC 63323- 694 -04 694104

ACETYLCYSTEINE
SOLUTION, USP

20% (200 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

4 mL Vial Rx Only

vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL (20%) carton

NDC 63323- 692 -10 692110


ACETYLCYSTEINE
SOLUTION, USP

20% (200 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

3 x 10 mL Vials Rx only

ace42958A
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL (20%) container

NDC 63323- 692 -10 692110


ACETYLCYSTEINE SOLUTION, USP

20% (200 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

10 mL Vial

Rx Only

10ml Container label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mL (20%) carton

NDC 63323- 690 -30 690130

ACETYLCYSTEINE SOLUTION, USP

20% (200 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

3 x 30 mL Vials

Rx only

ace42912B
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mL (20%) container

NDC 63323 -690 -30 690130

ACETYLCYSTEINE SOLUTION, USP

20% (200 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

30 mL VIal

Rx only

Container label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 mL (10%) carton

NDC 63323- 695 -04 695104

ACETYLCYSTEINE

SOLUTION, USP

10% (100 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

25 x 4 mL Vials

Rx only

ace42962A
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 mL (10%) container

NDC 63323- 695 -04 695104

ACETYLCYSTEINE

SOLUTION, USP

10% (100 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

4 mL Vial

Rx only

4 ml Container label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL (10%) carton

NDC 63323- 693 -10 693110

ACETYLCYSTEINE

SOLUTION, USP

10% (100 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

3 x 10 mL Vials

Rx only

ace42959A
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL (10%) container

NDC 63323- 693 -10 693110

ACETYLCYSTEINE

SOLUTION, USP

10% (100 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

10 mL Vial

Rx Only

10 ml Container label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mL (10%) carton

NDC 63323- 691 -30 691130

ACETYLCYSTEINE

SOLUTION, USP

10% (100 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE

3 x 30 mL Vials

Rx only

ace42957A
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mL (10%) container

NDC 63323- 691 -30 691130

ACETYLCYSTEINE

SOLUTION, USP

10% (100 mg/mL)

For Inhalation (Mucolytic Agent) or Oral Administration (Acetaminophen Antidote)

NOT FOR INJECTION. PRESERVATIVE FREE 30 mL Vial

Rx only

30 ml Container label
(click image for full-size original)
ACETYLCYSTEINE acetylcysteine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-695
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-695-04 25 VIAL in 1 CARTON contains a VIAL
1 4 mL in 1 VIAL This package is contained within the CARTON (63323-695-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204674 03/31/2014
ACETYLCYSTEINE acetylcysteine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-693
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-693-10 3 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (63323-693-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204674 03/31/2014
ACETYLCYSTEINE acetylcysteine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-691
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-691-30 3 VIAL in 1 CARTON contains a VIAL
1 30 mL in 1 VIAL This package is contained within the CARTON (63323-691-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204674 03/31/2014
ACETYLCYSTEINE acetylcysteine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-694
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-694-04 25 VIAL in 1 CARTON contains a VIAL
1 4 mL in 1 VIAL This package is contained within the CARTON (63323-694-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203853 09/01/2012
ACETYLCYSTEINE acetylcysteine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-692
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-692-10 3 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (63323-692-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203853 09/01/2012
ACETYLCYSTEINE acetylcysteine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-690
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE (ACETYLCYSTEINE) ACETYLCYSTEINE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-690-30 3 VIAL in 1 CARTON contains a VIAL
1 30 mL in 1 VIAL This package is contained within the CARTON (63323-690-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203853 09/01/2012
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
GLAND PHARMA LIMITED 918601238 manufacture (63323-695), manufacture (63323-693), manufacture (63323-691), manufacture (63323-694), manufacture (63323-692), manufacture (63323-690)

Revised: 10/2022 Fresenius Kabi USA, LLC

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