Home NDC 58602-705 Famotidine
Product NDC 58602-705
11-digit product format 586020705
Labeler code 58602
Product ID 58602-705_83d5769e-ef9c-4ce5-afd5-a2dd7496274a
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurohealth LLC
Application ANDA206531
Marketing category ANDA
Marketing start 2016-04-26
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 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 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 58602-705-03 Famotidine 10 in 1 BLISTER PACK TABLET, FILM COATED 10 13 58602-705-09 Famotidine 3 in 1 CARTON TABLET, FILM COATED 3 13 58602-705-12 Famotidine 4 in 1 CARTON TABLET, FILM COATED 4 13 58602-705-14 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-14 Famotidine 50 in 1 BOTTLE TABLET, FILM COATED 50 13 58602-705-15 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-15 Famotidine 60 in 1 BOTTLE TABLET, FILM COATED 60 13 58602-705-19 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-19 Famotidine 90 in 1 BOTTLE TABLET, FILM COATED 90 13 58602-705-32 Famotidine 180 in 1 BOTTLE TABLET, FILM COATED 180 13 58602-705-32 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-34 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-34 Famotidine 200 in 1 BOTTLE TABLET, FILM COATED 200 13 58602-705-39 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-39 Famotidine 365 in 1 BOTTLE TABLET, FILM COATED 365 13 58602-705-40 Famotidine 500 in 1 BOTTLE TABLET, FILM COATED 500 13 58602-705-40 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-41 Famotidine 1000 in 1 BOTTLE TABLET, FILM COATED 1000 13 58602-705-41 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-44 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-44 Famotidine 400 in 1 BOTTLE TABLET, FILM COATED 400 13 58602-705-84 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-84 Famotidine 30 in 1 BOTTLE TABLET, FILM COATED 30 13 58602-705-88 Famotidine 750 in 1 BOTTLE TABLET, FILM COATED 750 13 58602-705-88 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 13 58602-705-93 Famotidine 90 in 1 BOTTLE TABLET, FILM COATED 90 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-705 FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC] 13 Current NDC, Legacy NDC, 26 package rows 20250321_756c7234-6a63-4b1b-be36-2b1ed09e67a0.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 2 of 2 · 38 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Famotidine FAMOTIDINE LEADER/ CARDINAL HEALTH 110, INC. cdd509c4-331b-4aee-935c-dfc44d5943ed 2025-04-05 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE WALGREEN CO. e9ded705-85c7-1380-e053-2995a90a68ec 2025-04-05 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Best Choice fadb9d53-4cc6-83d6-e053-6394a90aa2e3 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Amerisource Bergen a5d88925-efca-4240-9eb5-6a9d0ac7a67e 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Better Living Brands LLC f6f07e25-2b31-b0c4-e053-6294a90a8ffb 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE HARRIS TEETER, LLC e49e087c-ee20-3174-e053-2995a90a1d09 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE CVS Pharmacy, Inc. c4e1ef3d-7391-66f5-e053-2995a90abc00 2025-03-28 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Harris Teeter bc548297-7646-4dbf-bfc5-65f2bc629676 2025-03-26 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Aurohealth LLC 27ecf5c1-202a-44cf-94f9-d7fefa027e1e 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE WALGREEN CO. 316e3815-6ae1-47c3-8a75-fd57f8434a6f 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Wal-Mart Stores, Inc. 018b02e8-1005-4736-a4fc-962881f52adf 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Aurohealth LLC 756c7234-6a63-4b1b-be36-2b1ed09e67a0 2025-03-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 ndc (product): 58602-705 Zantac 360, Travel BASIX FAMOTIDINE TABLET, FILM-COATED Lil' Drug Store Products, Inc ea38535a-c9db-d03f-e053-2a95a90adf2d 2024-11-19 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 FAMOTIDINE Navajo Manufacturing Company Inc. e328c59c-baed-0e4e-e053-2995a90ab85c 2024-04-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE BluePoint Laboratories befd8d44-c6f7-eca2-e053-2995a90a714b 2023-03-23 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Zantac 360 2 per blister 6 blisters FAMOTIDINE JC World Bell Wholesale Co., Inc. fd61a2d6-5c8a-4e7a-8b19-37406b90f778 2022-08-15 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Proficient Rx LP 68120de1-fd9a-4f93-b218-d99ed7c5080a 2022-06-01 Warnings Exact identifier application applno (ANDA): 206531 application number: ANDA206531 Famotidine FAMOTIDINE Proficient Rx LP 787724dc-0b4b-4973-852e-c7d722f637b0 2022-05-01 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 Marketing end Sample Exclude flag Status 58602-705-03 58602070503 10 in 1 BLISTER PACK Historical 58602-705-09 58602070509 3 BLISTER PACK in 1 CARTON (58602-705-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03) 3 blister pack 2016-04-26 0000-00-00 No No Current 58602-705-12 58602070512 4 BLISTER PACK in 1 CARTON (58602-705-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03) 4 blister pack 2016-04-26 0000-00-00 No No Current 58602-705-14 58602070514 1 BOTTLE in 1 CARTON (58602-705-14) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-12-21 0000-00-00 No No Current 58602-705-15 58602070515 1 BOTTLE in 1 CARTON (58602-705-15) / 60 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2016-04-26 0000-00-00 No No Current 58602-705-19 58602070519 1 BOTTLE in 1 CARTON (58602-705-19) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2016-04-26 0000-00-00 No No Current 58602-705-32 58602070532 1 BOTTLE in 1 CARTON (58602-705-32) / 180 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-02-18 0000-00-00 No No Current 58602-705-34 58602070534 1 BOTTLE in 1 CARTON (58602-705-34) / 200 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-22 0000-00-00 No No Current 58602-705-39 58602070539 1 BOTTLE in 1 CARTON (58602-705-39) / 365 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-22 0000-00-00 No No Current 58602-705-40 58602070540 1 BOTTLE in 1 CARTON (58602-705-40) / 500 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-22 0000-00-00 No No Current 58602-705-41 58602070541 1 BOTTLE in 1 CARTON (58602-705-41) / 1000 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-09-04 0000-00-00 No No Current 58602-705-44 58602070544 1 BOTTLE in 1 CARTON (58602-705-44) / 400 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-22 0000-00-00 No No Current 58602-705-84 58602070584 1 BOTTLE in 1 CARTON (58602-705-84) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2019-05-13 0000-00-00 No No Current 58602-705-88 58602070588 1 BOTTLE in 1 CARTON (58602-705-88) / 750 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-07-22 0000-00-00 No No Current 58602-705-93 58602070593 90 TABLET, FILM COATED in 1 BOTTLE (58602-705-93) 2016-04-26 0000-00-00 No No Current