Famotidine

Product NDC: 55319-427
11-digit product format: 553190427
Labeler code: 55319
Product ID: 55319-427_7fb4e13d-ec82-e5a6-6cd5-f0f6eebf7635
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Family Dollar Stores, Inc.
Application: ANDA077367
Marketing category: ANDA
Marketing start: 2021-11-01
Substance: FAMOTIDINE
Active strength: 20 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 55319-427
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

Additional Listing Data#

Finished product: Yes
Brand name base: Famotidine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	20 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
0f81e8ac-ddad-13d6-e883-6a5310e058de	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
55319-427-10	Famotidine	100 in 1 BOTTLE	TABLET	100	3
55319-427-10	Famotidine	1 in 1 CARTON	TABLET	1	3
55319-427-25	Famotidine	1 in 1 CARTON	TABLET	1	3
55319-427-25	Famotidine	25 in 1 BOTTLE	TABLET	25	3
55319-427-50	Famotidine	50 in 1 BOTTLE	TABLET	50	3
55319-427-50	Famotidine	1 in 1 CARTON	TABLET	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-427	FAMOTIDINE TABLET [FAMILY DOLLAR STORES, INC.]	2	Current NDC, 6 package rows	20241024_0f81e8ac-ddad-13d6-e883-6a5310e058de.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
199047	famotidine 10 MG Oral Tablet	PSN	0f81e8ac-ddad-13d6-e883-6a5310e058de	3
310273	famotidine 20 MG Oral Tablet	PSN	0f81e8ac-ddad-13d6-e883-6a5310e058de	3
199047	famotidine 10 MG Oral Tablet	SCD	0f81e8ac-ddad-13d6-e883-6a5310e058de	3
310273	famotidine 20 MG Oral Tablet	SCD	0f81e8ac-ddad-13d6-e883-6a5310e058de	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55319-427-10	55319042710	1 BOTTLE in 1 CARTON (55319-427-10) / 100 TABLET in 1 BOTTLE	1 bottle	2023-10-01	No	No	Current
55319-427-25	55319042725	1 BOTTLE in 1 CARTON (55319-427-25) / 25 TABLET in 1 BOTTLE	1 bottle	2023-10-01	No	No	Current
55319-427-50	55319042750	1 BOTTLE in 1 CARTON (55319-427-50) / 50 TABLET in 1 BOTTLE	1 bottle	2023-10-01	No	No	Current