Famotidine

Product NDC: 49035-118
11-digit product format: 490350118
Labeler code: 49035
Product ID: 49035-118_0e787eb2-9af1-cd26-560d-cf34f2daf466
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: ANDA077367
Marketing category: ANDA
Marketing start: 2012-07-05
Marketing end: 0000-00-00
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: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49035-118		D	Discontinued by firm	2026-08-17
excluded package	package	49035-118	49035-118-12	D	Discontinued by firm	2026-08-17
excluded package	package	49035-118	49035-118-30	D	Discontinued by firm	2026-08-17
excluded package	package	49035-118	49035-118-90	D	Discontinued by firm	2026-08-17

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 · 32 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	49035-118-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49035-118-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49035-118-90	`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	49035-118-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49035-118-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49035-118-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49035-118-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49035-118-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49035-118-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49035-118-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49035-118-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49035-118-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49035-118-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49035-118-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49035-118-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49035-118-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49035-118-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49035-118-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49035-118-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49035-118-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49035-118-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-118-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-118-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-118-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-118-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-118-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-118-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49035-118-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49035-118-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49035-118-12	`ad56d346431e…`	`cc804d4bbf1e…`

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
A077367-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2006-09-25
A077367-002	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2001-08-17

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 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-118-90	EA - Each	49035-118	b4a08494-45e9-4607-9596-3731e3267cf8	1	2019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET [WAL-MART STORES INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET [WAL-MART STORES INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-118	FAMOTIDINE TABLET [WAL-MART STORES INC]	7	Legacy NDC	20241025_c8171b38-0dfd-d2b0-9331-8a82c29c8ab2.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Chain Drug Marketing Association INC	7fbc5e10-30c6-7f8d-1040-d48a80fe4d79	2025-07-22	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367
Acid Reducer Original Strength	FAMOTIDINE	Dr.Reddys Laboratories Inc.	ca039876-f7e5-3e60-da5a-a1f40637a417	2025-07-17	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367
Famotidine	FAMOTIDINE	Albertsons Companies	27314f55-5e31-703c-b98c-ec89bf308472	2025-07-17	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367
Famotidine	FAMOTIDINE	Family Dollar Stores, Inc.	0f81e8ac-ddad-13d6-e883-6a5310e058de	2025-07-17	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367
Famotidine	FAMOTIDINE	Discount Drug Mart, Inc	c5d81352-c45b-3ea1-9974-8a096bd05009	2025-07-17	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367
Famotidine	FAMOTIDINE	Chain Drug Consortium, LLC	937f7bce-955b-9418-5aed-2e84aee50de3	2025-07-17	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367
Famotidine	FAMOTIDINE	Chain Drug Marketing Association INC	1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a	2025-07-17	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367
Famotidine	FAMOTIDINE	Dr.Reddys Laboratories Limited	387088a6-8eaa-fc49-8050-a546d0f0fd32	2025-06-03	Warnings	Exact identifier application applno (ANDA): 077367 application number: ANDA077367

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
49035-118-12	49035011812	1 BLISTER PACK in 1 CARTON (49035-118-12) > 12 TABLET in 1 BLISTER PACK	1 blister pack	2012-07-05	0000-00-00	No	No	Current
49035-118-30	49035011830	1 BOTTLE in 1 CARTON (49035-118-30) > 30 TABLET in 1 BOTTLE	1 bottle	2012-07-05	0000-00-00	No	No	Current
49035-118-90	49035011890	1 BOTTLE in 1 CARTON (49035-118-90) > 90 TABLET in 1 BOTTLE	1 bottle	2012-07-05	0000-00-00	No	No	Current