Home NDC 85828-443 Acid Reducer
Product NDC 85828-443
11-digit product format 858280443
Labeler code 85828
Product ID 85828-443_39e5e058-6419-4d47-ab41-d051f58065a1
Type HUMAN OTC DRUG
Nonproprietary name Famotidine 20mg
Dosage form TABLET
Route ORAL
Labeler Grocery Outlet
Application ANDA215822
Marketing category ANDA
Marketing start 2026-03-20
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215822-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 A215822-002 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2022-01-28
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 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 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 1 · 17 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Acid Reducer
Brand name suffix Maximum Strength
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 85828-443-25 Acid ReducerMaximum Strength 1 in 1 CARTON TABLET 1 6 85828-443-25 Acid ReducerMaximum Strength 25 in 1 BOTTLE TABLET 25 6
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85828-443-25 85828044325 1 BOTTLE in 1 CARTON (85828-443-25) / 25 TABLET in 1 BOTTLE 1 bottle 2026-03-20 No No Current