Home NDC 50594-002 sound body acid reducer
Product NDC 50594-002
11-digit product format 505940002
Labeler code 50594
Product ID 50594-002_a93dda73-9760-425d-88b9-22285fe45820
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Big Lots Stores, Inc.
Application ANDA077351
Marketing category ANDA
Marketing start 2015-05-21
Marketing end 0000-00-00
Substance FAMOTIDINE
Active strength 20 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET [BIG LOTS STORES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50594-002 SOUND BODY ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [BIG LOTS STORES, INC.] 8 Legacy NDC 20250309_668526a2-f7c9-48e8-8aed-62089c6b6829.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50594-002-01 50594000201 1 BOTTLE in 1 CARTON (50594-002-01) > 85 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-03-09 0000-00-00 No No Current 50594-002-63 50594000263 1 BOTTLE in 1 CARTON (50594-002-63) > 25 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-05-21 0000-00-00 No No Current