FAMOTIDINE

Product NDC: 55648-374
11-digit product format: 556480374
Labeler code: 55648
Product ID: 55648-374_d0e9c888-c641-40a8-9338-d83b6de02385
Type: HUMAN OTC DRUG
Nonproprietary name: FAMOTIDINE
Dosage form: TABLET
Route: ORAL
Labeler: WOCKHARDT LIMITED
Application: ANDA090837
Marketing category: ANDA
Marketing start: 2010-08-06
Marketing end: 0000-00-00
Substance: FAMOTIDINE
Active strength: 20 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-374		I	Inactivated by FDA	2026-08-03
excluded package	package	55648-374	55648-374-00	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-374	55648-374-01	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-374	55648-374-05	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-374	55648-374-07	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-374	55648-374-08	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-374	55648-374-09	I	Inactivated by FDA	2026-08-03

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 3 · 154 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	55648-374-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-374-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-374-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-374-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-374-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-374-07	`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	55648-374-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-374-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-374-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-374-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-374-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-374-07	`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	55648-374-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-374-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-374-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-374-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-374-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-374-07	`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	55648-374-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-374-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-374-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-374-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-374-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-374-07	`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	55648-374-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-374-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-374-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-374-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-374-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-374-07	`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	55648-374-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-374-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-374-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-374-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-374-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-374-07	`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	55648-374-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-374-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-374-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-374-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-374-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-374-07	`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	55648-374-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-374-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-374-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-374-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-374-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-374-07	`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	55648-374-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-374-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-374-08	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090837-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2010-08-04

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090837-001	FAMOTIDINE	20MG	TABLET / ORAL	2010-08-04	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae	Product name	7	20260317
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
cf645750-2e70-f6e1-c05a-a52847def5dd	Product name	9	20250312
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
55648-374-00	Famotidine Tablets, USP 20 mg
55648-374-01	Famotidine Tablets, USP 20 mg
55648-374-05	Famotidine Tablets, USP 20 mg
55648-374-07	Famotidine Tablets, USP 20 mg
55648-374-08	Famotidine Tablets, USP 20 mg
55648-374-09	Famotidine Tablets, USP 20 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-374-00	FAMOTIDINE	38000 in 1 DRUM	TABLET	38000	2
55648-374-01	FAMOTIDINE	1 in 1 CARTON	TABLET	1	2
55648-374-01	FAMOTIDINE	30 in 1 BOTTLE	TABLET	30	2
55648-374-05	FAMOTIDINE	1 in 1 CARTON	TABLET	1	2
55648-374-05	FAMOTIDINE	500 in 1 BOTTLE	TABLET	500	2
55648-374-07	FAMOTIDINE	10 in 1 CARTON	TABLET	10	2
55648-374-07	FAMOTIDINE	10 in 1 BLISTER PACK	TABLET	10	2
55648-374-08	FAMOTIDINE	1 in 1 CARTON	TABLET	1	2
55648-374-08	FAMOTIDINE	30 in 1 BOTTLE	TABLET	30	2
55648-374-09	FAMOTIDINE	6500 in 1 DRUM	TABLET	6500	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-374	FAMOTIDINE TABLET [WOCKHARDT LIMITED]	2	Legacy NDC, 10 package rows	20120807_fdff466f-9884-4bbd-89af-0e186a54801b.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	fdff466f-9884-4bbd-89af-0e186a54801b	2
310273	famotidine 20 MG Oral Tablet	SCD	fdff466f-9884-4bbd-89af-0e186a54801b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-374-00	55648037400	38000 in 1 DRUM	Historical
55648-374-01	55648037401	1 in 1 CARTON	Historical
55648-374-05	55648037405	1 in 1 CARTON	Historical
55648-374-07	55648037407	10 in 1 CARTON	Historical
55648-374-08	55648037408	1 in 1 CARTON	Historical
55648-374-09	55648037409	6500 in 1 DRUM	Historical