Home NDC 70000-0539-1 leader acid reducer
Product NDC 70000-0539
Requested package NDC 70000-0539-1
11-digit product format 700000539
Labeler code 70000
Product ID 70000-0539_ef33b7e6-7596-405c-9ef7-02c6f52935bc
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 110, LLC. dba Leader
Application ANDA075400
Marketing category ANDA
Marketing start 2020-01-28
Marketing end 2022-05-31
Substance FAMOTIDINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0539-1 70000053901 30 BLISTER PACK in 1 CARTON (70000-0539-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK 30 blister pack 2020-01-28 2022-05-31 No No Current