CEFIXIME (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Cefixime for oral suspension USP, 100 mg/5 mL is an off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 100 mg of cefixime as the trihydrate and is supplied as follows:

NDC 68180-405-01 — 50 mL Bottle

Prior to reconstitution: Store drug powder at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

After reconstitution: Store at room temperature or under refrigeration.

Keep tightly closed.

Cefixime for oral suspension USP, 200 mg/5 mL is an off-white to pale yellow colored powder. After reconstituted as directed, each 5 mL of reconstituted suspension contains 200 mg of cefixime as the trihydrate and is supplied as follows:

NDC 68180-407-03 — 50 mL Bottle

NDC 68180-407-04 — 75 mL Bottle

Prior to reconstitution: Store drug powder at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

After reconstitution: Store at room temperature or under refrigeration.

Keep tightly closed.

Cefixime capsules, 400 mg is size “0” capsule with pink opaque cap and pink opaque body, imprinted with “LU” on cap and “U43” on body in black ink, containing white to yellowish white granular powder containing 400 mg of cefixime as the trihydrate and is supplied as follows:

NDC 68180-423-08 — Bottle of 50 capsules

NDC 68180-423-11 — Unit dose Package of 10 (1 blister of 10 capsules)

Store at 20 to 25°C (68 to 77°F) [See USP Controlled Temperature].

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

Counsel patients that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefixime for oral suspension or other antibacterial drugs in the future.

Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Mandideep 462 046

INDIA

Revised: July 2019 ID#: 259077

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CEFIXIME FOR ORAL SUSPENSION USP

100 mg/5 mL

Rx only

NDC 68180-405-01: Bottle of 50 mL

CEFIXIME FOR ORAL SUSPENSION USP

200 mg/5 mL

Rx only

NDC 68180-407-03: Bottle of 50 mL

NDC 68180-407-04: Bottle of 75 mL

CEFIXIME CAPSULES

400 mg

Rx only

NDC 68180-416-08 — Bottle of 50 capsules

CEFIXIME CAPSULES

400 mg

Rx only

NDC 68180-416-11 — Blister

Unit dose Package of 10 (1 blister of 10 capsules)

CEFIXIME CAPSULES

400 mg

Rx only

NDC 68180-416-11 — Carton

CEFIXIME CAPSULES

400 mg

Rx only

NDC 68180-423-08 — Bottle of 50 capsules

CEFIXIME CAPSULES

400 mg

Rx only

NDC 68180-423-11 — Blister

Unit dose Package of 10 (1 blister of 10 capsules)

CEFIXIME CAPSULES

400 mg

Rx only

NDC 68180-423-11 — Carton

CEFIXIME cefixime powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-405 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE SODIUM BENZOATE STRAWBERRY SUCROSE XANTHAN GUM

Product Characteristics Color WHITE (off-white to pale yellow) Score Shape Size Flavor STRAWBERRY (Strawberry) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-405-01 50 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065129 04/24/2015

CEFIXIME cefixime powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-407 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 200 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE SODIUM BENZOATE STRAWBERRY SUCROSE XANTHAN GUM

Product Characteristics Color WHITE (Off White to Pale Yellow Powder) Score Shape Size Flavor STRAWBERRY (Strawberry) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-407-03 50 mL in 1 BOTTLE None 2 NDC:68180-407-04 75 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065355 04/24/2015

CEFIXIME cefixime capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-416 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 400 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE FERRIC OXIDE RED FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE MANNITOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE TITANIUM DIOXIDE

Product Characteristics Color PINK (Pink Opaque Cap) , PINK (Pink Opaque Body) Score no score Shape CAPSULE Size 26mm Flavor Imprint Code LU;U43 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-416-11 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68180-416-11) 2 NDC:68180-416-08 50 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065129 12/01/2018 10/31/2020

CEFIXIME cefixime capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-423 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 400 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM FERRIC OXIDE RED FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE MANNITOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE TITANIUM DIOXIDE

Product Characteristics Color PINK (Pink Opaque Cap) , PINK (Pink Opaque Body) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code LU;U43 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-423-11 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68180-423-11) 2 NDC:68180-423-08 50 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA203195 10/14/2020

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		725504448	API MANUFACTURE (68180-405), API MANUFACTURE (68180-407), API MANUFACTURE (68180-416), API MANUFACTURE (68180-423), MANUFACTURE (68180-405), MANUFACTURE (68180-407), MANUFACTURE (68180-416), MANUFACTURE (68180-423), PACK (68180-405), PACK (68180-407), PACK (68180-416), PACK (68180-423)

Revised: 01/2023 Lupin Pharmaceuticals, Inc.