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Famotidine

Famotidine Tablets USP

Approved
Approval ID

85c7d20d-3dec-b918-4c1d-8ca1db214e48

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers
FDA

AvPAK

DUNS: 832926666

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Famotidine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-303
Application NumberANDA075805
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (9)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

Famotidine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50268-304
Application NumberANDA075805
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (9)

TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMOTIDINEActive
Quantity: 40 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 10/7/2014

HOW SUPPLIED

Famotidine Tablets USP (white round tablets) containing 20mg of famotidine and engraved withCTI 121.

NDC 50268-303-15 10 Tablets per card, 5 cards per carton

Famotidine Tablets USP (white round tablets) containing 40mg of famotidine and engraved withCTI 122.

NDC 50268-304-15 10 Tablets per card, 5 cards per carton

Dispensed in Blister Punch Material. For Institutional Use Only.

STORAGE

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

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 06/12 AV 09/14 (P)
CTI-12 Rev. C

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Famotidine - FDA Drug Approval Details