Home Applications 075400 Application 075400
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FAMOTIDINE FAMOTIDINE TABLET;ORAL 10MG No No
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 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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075400-001 FAMOTIDINE 10MG TABLET / ORAL 2005-03-18 cb3db0bc1861…
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 1 · 19 matching rows.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 103 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59779-141 acid controller Famotidine CVS Pharmacy ANDA Current 59779-141 acid controller Famotidine CVS Pharmacy ANDA Current 59779-141 acid controller Famotidine CVS Pharmacy ANDA Current 59779-141 acid controller Famotidine CVS Pharmacy ANDA Current 59779-141 acid controller Famotidine CVS Pharmacy ANDA Current 62011-0142 health mart famotidine Famotidine Strategic Sourcing Services LLC ANDA Current 62011-0142 health mart famotidine Famotidine Strategic Sourcing Services LLC ANDA Current 62011-0142 health mart famotidine Famotidine Strategic Sourcing Services LLC ANDA Current 62011-0142 health mart famotidine Famotidine McKesson ANDA Current 63187-999 heartburn relief Famotidine Proficient Rx LP ANDA Current 63187-999 heartburn relief Famotidine Proficient Rx LP ANDA Current 68151-2591 Good Neighbor Pharmacy acid reducer Famotidine Carilion Materials Management ANDA Current 69256-141 harris teeter acid reducer Famotidine Harris Teeter, LLC ANDA Current 69256-141 harris teeter acid reducer Famotidine Harris Teeter, LLC ANDA Current 69256-141 harris teeter acid reducer Famotidine Harris Teeter, LLC ANDA Current 69256-141 harris teeter acid reducer Famotidine Harris Teeter, LLC ANDA Current 70000-0539 leader acid reducer Famotidine Cardinal Health ANDA Current 70000-0539 leader acid reducer Famotidine Cardinal Health 110, LLC. dba Leader ANDA Current 72288-141 basic care acid reducer Famotidine Amazon.com Services LLC ANDA Current 72288-141 basic care acid reducer Famotidine Amazon.com Services Inc. ANDA Current 72288-141 basic care acid reducer Famotidine Amazon.com Services LLC ANDA Current 72288-141 basic care acid reducer Famotidine Amazon.com Services LLC ANDA Current 81522-141 caring mill famotidine Famotidine FSA Store Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30873 ORIG 2003-04-10