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:
-
Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis , 1981; 61 (Suppl III): 45-51.
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Am Rev Respir Dis , 1960; 82:627−639.
Manufactured For:
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
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
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
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
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
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
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
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
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
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
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
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
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ACETYLCYSTEINE acetylcysteine solution | |||||||||||||||||
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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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https://medlibrary.org/lib/rx/meds/acetylcysteine-14/page/4/