Home NDC 43602-501-05 FAMOTIDINE
Product NDC 43602-501
Requested package NDC 43602-501-05
11-digit product format 436020501
Labeler code 43602
Product ID 43602-501_979f9de7-3cc6-4f7f-aaed-96ee208606b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascent Pharmaceuticals, Inc.
Application ANDA215689
Marketing category ANDA
Marketing start 2021-10-15
Marketing end 0000-00-00
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 2022-12-31
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43602-501 43602-501-05 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215689-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 A215689-002 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 68 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 2026-08-18 06:07:40 2026-07 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215689-001 FAMOTIDINE 20MG TABLET / ORAL AB 2021-10-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A215689-002 FAMOTIDINE 40MG TABLET / ORAL AB 2021-10-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43602-501 FAMOTIDINE TABLET, FILM COATED [ASCENT PHARMACEUTICALS, INC.] 1 Legacy NDC 20211027_3bc583e9-a4b0-4941-9d1c-3521d49a37ef.zip
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43602-501-05 43602050105 500 TABLET, FILM COATED in 1 BOTTLE (43602-501-05) 2021-10-15 0000-00-00 No No Current