Home NDC 46122-737 Famotidine
Product NDC 46122-737
11-digit product format 461220737
Labeler code 46122
Product ID 46122-737_d51e75bd-4703-4fc4-b5cd-94b17f72b9a6
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amerisource Bergen
Application ANDA206531
Marketing category ANDA
Marketing start 2023-07-20
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 A206531-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 A206531-002 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2016-04-26
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 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206531-001 FAMOTIDINE 10MG TABLET / ORAL 2016-04-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206531-002 FAMOTIDINE 20MG TABLET / ORAL 2016-04-26 74a2ff9319b5…
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 46122-737-63 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 3 46122-737-63 Famotidine 25 in 1 BOTTLE TABLET, FILM COATED 25 3 46122-737-71 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 3 46122-737-71 Famotidine 50 in 1 BOTTLE TABLET, FILM COATED 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-737 FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN] 3 Current NDC, 4 package rows 20250425_d8df03ab-7c5c-4c8b-a3fb-6c6081e081e7.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 2 · 38 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Famotidine FAMOTIDINE Aurohealth LLC 5b161f25-c578-4ff4-a931-ff3a1e681c50 2026-09-04 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 FAMOTIDINE Select Consumer Group LLC 529cef2d-e6cc-3b37-e063-6294a90aff59 2026-06-27 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE CVS Pharmacy, Inc. 7357f67e-0fc6-4555-aa8b-1df09cba9feb 2026-06-24 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Family Dollar Stores, LLC 4dc7c2c4-83c7-608d-e063-6294a90a90eb 2026-06-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 Cool Mint FAMOTIDINE Chattem, Inc. 19fe7c6e-243c-4005-a63a-f8cac1ce55c8 2025-09-30 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 FAMOTIDINE Chattem, Inc. 89f60eb1-359b-40e8-ae8b-65aec9cd5b1f 2025-05-09 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Magno-Humphries, Inc. f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9 2025-05-02 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Magno-Humphries, Inc. ed32f72a-e220-440f-a74f-b754a313f004 2025-05-02 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE LEADER/ CARDINAL HEALTH 110, INC. 78b168f1-846d-4e88-a8ee-845c41c9dcbe 2025-04-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Better Living Brands, LLC f6f0230c-44fb-6c36-e053-6394a90ac43e 2025-04-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Fred's, Inc. 81b105a1-01fe-51d7-e053-2991aa0a71bc 2025-04-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE CVS Pharmacy, Inc. c4e35c7e-5c2f-4252-e053-2a95a90a8268 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE CVS Pharmacy, Inc. 479a1437-a212-49d9-b272-758c0e5b7203 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Best Choice fadbd056-6510-f864-e053-6294a90aa67b 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Aurohealth LLC f2b911c7-ce24-4d3d-8fb6-c34980191f40 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Aurohealth LLC 6d0d8839-0680-45f6-96db-2d8edc9d4682 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Wal-Mart Stores, Inc. 43fb44ea-07a1-4df9-8b4a-b2249757208e 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Amerisource Bergen d8df03ab-7c5c-4c8b-a3fb-6c6081e081e7 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 46122-737 Famotidine FAMOTIDINE WALGREEN CO. 2766ffe7-2f1c-48c8-8f67-0a2819dcc3be 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE WALGREEN CO. d0f74e78-7afb-49c2-e053-2a95a90a31dc 2025-04-22 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46122-737-63 46122073763 1 BOTTLE in 1 CARTON (46122-737-63) / 25 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-07-20 No No Current 46122-737-71 46122073771 1 BOTTLE in 1 CARTON (46122-737-71) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-07-20 No No Current