Home NDC 51316-816 ACID REDUCER
Product NDC 51316-816
11-digit product format 513160816
Labeler code 51316
Product ID 51316-816_35e8d139-0f84-4c0e-b43b-bf28f8d9f28e
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application ANDA075400
Marketing category ANDA
Marketing start 2026-08-03
Substance FAMOTIDINE
Active strength 10 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 43 .
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 A075400-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2005-03-18
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ACID REDUCER
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 10 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 199047 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-816-39 51316081639 1 BOTTLE in 1 CARTON (51316-816-39) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-08-03 No No Current