Home NDC 49035-650-71 Equate Famotidine
Product NDC 49035-650
Requested package NDC 49035-650-71
11-digit product format 490350650
Labeler code 49035
Product ID 49035-650_f58d95e7-ece2-4080-adf8-8cb66cd19d71
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA077351
Marketing category ANDA
Marketing start 2007-05-02
Substance FAMOTIDINE
Active strength 20 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077351-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2006-09-25
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 3 · 42 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Equate Famotidine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QZO15J2Z8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310273 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49035-650-63 Equate Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 9 49035-650-63 Equate Famotidine 25 in 1 BOTTLE TABLET, FILM COATED 25 9 49035-650-71 Equate Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 9 49035-650-71 Equate Famotidine 50 in 1 BOTTLE TABLET, FILM COATED 50 9 49035-650-72 Equate Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 9 49035-650-72 Equate Famotidine 60 in 1 BOTTLE TABLET, FILM COATED 60 9 49035-650-78 Equate Famotidine 100 in 1 BOTTLE TABLET, FILM COATED 100 9 49035-650-78 Equate Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 9 49035-650-82 Equate Famotidine 100 in 1 BOTTLE TABLET, FILM COATED 100 9 49035-650-82 Equate Famotidine 2 in 1 CARTON TABLET, FILM COATED 2 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC] 2 FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMOTIDINE TABLET [SAFECOR HEALTH, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-650 EQUATE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [WAL-MART STORES INC] 8 Current NDC, Legacy NDC, 10 package rows 20250212_8ac94821-aa78-4e57-bc9a-f1f2a0e47b07.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49035-650-71 49035065071 1 BOTTLE in 1 CARTON (49035-650-71) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2007-05-02 0000-00-00 No No Current