Famotidine

Product NDC: 53943-100
11-digit product format: 539430100
Labeler code: 53943
Product ID: 53943-100_a9ec4a5f-1e94-74d2-5fa5-7f032c87e11b
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Discount Drug Mart, Inc
Application: ANDA077367
Marketing category: ANDA
Marketing start: 2021-01-01
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 1.

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 · 78 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	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…`
2021-12-28 21:50 UTC	2021-12	A077367-002	FAMOTIDINE	10MG	TABLET / ORAL	2001-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077367-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`87673890dc5c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199047	Internal RxNorm lookup
310273	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c5d81352-c45b-3ea1-9974-8a096bd05009	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-100-30	Famotidine	1 in 1 CARTON	TABLET	1		7
53943-100-30	Famotidine	30 in 1 BOTTLE	TABLET	30		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-100	FAMOTIDINE TABLET [DISCOUNT DRUG MART, INC]	6	Current NDC, Legacy NDC, 2 package rows	20241024_c5d81352-c45b-3ea1-9974-8a096bd05009.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 ndc (product): 53943-100
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199047	famotidine 10 MG Oral Tablet	PSN	c5d81352-c45b-3ea1-9974-8a096bd05009	7
310273	famotidine 20 MG Oral Tablet	PSN	c5d81352-c45b-3ea1-9974-8a096bd05009	7
199047	famotidine 10 MG Oral Tablet	SCD	c5d81352-c45b-3ea1-9974-8a096bd05009	7
310273	famotidine 20 MG Oral Tablet	SCD	c5d81352-c45b-3ea1-9974-8a096bd05009	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-100-30	53943010030	1 BOTTLE in 1 CARTON (53943-100-30) / 30 TABLET in 1 BOTTLE	1 bottle	2021-01-01	0000-00-00	No	No	Current