Famotidine

Product NDC: 63868-563
11-digit product format: 638680563
Labeler code: 63868
Product ID: 63868-563_fdda1b6b-31b8-472c-bbc5-5990c3a2c543
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: C.D.M.A., Inc.
Application: ANDA206531
Marketing category: ANDA
Marketing start: 2019-08-20
Marketing end: 0000-00-00
Substance: FAMOTIDINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-563		D	Discontinued by firm		2026-10-05
excluded package	package	63868-563	63868-563-60	D	Discontinued by firm		2026-10-05

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-563-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-563-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-563-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-563-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-563-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-563-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63868-563-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63868-563-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63868-563-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63868-563-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63868-563-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63868-563-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-563-60	63868056360	1 BOTTLE in 1 CARTON (63868-563-60) > 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine	C.D.M.A., Inc. \| Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	2021-12-24	Human OTC Drug Label	5