Home NDC 67296-2133 Famotidine
Product NDC 67296-2133
11-digit product format 672962133
Labeler code 67296
Product ID 67296-2133_46aca2aa-0c5d-7520-e063-6394a90a959f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form TABLET
Route ORAL
Labeler Redpharm Drug
Application ANDA075302
Marketing category ANDA
Marketing start 2023-10-19
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 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075302-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 A075302-002 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16
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 3 · 86 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 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075302-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075302-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075302-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075302-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075302-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075302-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075302-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075302-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075302-001 FAMOTIDINE 20MG TABLET / ORAL 2001-04-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075302-002 FAMOTIDINE 40MG TABLET / ORAL 2001-04-16 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 Famotidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 20 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 310273 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 67296-2133-3 Famotidine 30 in 1 BOTTLE TABLET 30 3
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 · 2 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 67296-2133-3 67296213303 30 TABLET in 1 BOTTLE (67296-2133-3) 30 tablet 2023-10-19 No No Current