Famotidine

Product NDC: 72559-038
11-digit product format: 725590038
Labeler code: 72559
Product ID: 72559-038_39334fb3-e395-7819-e063-6294a90a9073
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Little Pharma, Inc.
Application: ANDA215766
Marketing category: ANDA
Marketing start: 2025-05-15
Substance: FAMOTIDINE
Active strength: 10 mg/10mg
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 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
A215766-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2021-11-08
A215766-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2021-11-08

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 · 70 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	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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/10mg

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199047	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
33dc93a5-ee03-2e68-e063-6294a90aeee1	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
72559-038-23	Famotidine	300 mg in 1 BOTTLE	TABLET	300		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72559-038	FAMOTIDINE TABLET [LITTLE PHARMA, INC.]	1	Current NDC, 1 package rows	20250515_33dc93a5-ee03-2e68-e063-6294a90aeee1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goodmeds Famotidine 20mg 500 count	FAMOTIDINE 20MG	Cabinet Health P.B.C.	5592d0f0-03fd-c914-e063-6294a90a2826	2026-07-01	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766
Heartburn Relief	FAMOTIDINE	Shield Pharmaceuticals Corp	a12ec91d-244f-45c5-8590-d1e4485fe361	2025-10-31	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766
Famotidine	FAMOTIDINE	Little Pharma, Inc.	33dc93a5-ee03-2e68-e063-6294a90aeee1	2025-07-05	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766 ndc (product): 72559-038
famotidine	FAMOTIDINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6	2024-03-27	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766
famotidine	FAMOTIDINE	Camber Consumer Care Inc	ebe3ca30-df25-4c56-8935-414a3431b5b9	2022-10-11	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766

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	33dc93a5-ee03-2e68-e063-6294a90aeee1	2
199047	famotidine 10 MG Oral Tablet	SCD	33dc93a5-ee03-2e68-e063-6294a90aeee1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72559-038-23	72559003823	300 mg in 1 BOTTLE (72559-038-23)	300 mg	2025-05-15	No	No	Current