Home NDC 42507-141 acid reducer
Product NDC 42507-141
11-digit product format 425070141
Labeler code 42507
Product ID 42507-141_d614f778-d1b8-4fa4-94f8-59978dfbfb52
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler HyVee Inc
Application ANDA075400
Marketing category ANDA
Marketing start 2009-10-19
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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…
Additional Listing Data#
Finished product Yes
Brand name base acid reducer
Brand name suffix original strength
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42507-141-65 acid reduceroriginal strength 3 in 1 CARTON TABLET, FILM COATED 3 3 42507-141-65 acid reduceroriginal strength 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 42507-141-72 acid reduceroriginal strength 60 in 1 BOTTLE TABLET, FILM COATED 60 3 42507-141-72 acid reduceroriginal strength 1 in 1 CARTON TABLET, FILM COATED 1 3 42507-141-75 acid reduceroriginal strength 1 in 1 CARTON TABLET, FILM COATED 1 3 42507-141-90 acid reduceroriginal strength 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Socrata Ingredients# 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-141-65 42507014165 3 in 1 CARTON Historical 42507-141-72 42507014172 60 in 1 BOTTLE Historical 42507-141-75 42507014175 1 BOTTLE in 1 CARTON (42507-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE (42507-141-90) 1 bottle 2026-02-25 No No Current 42507-141-90 42507014190 90 in 1 BOTTLE Historical