Famotidine

Product NDC: 80425-0589
Requested package NDC: 80425-0589-3
11-digit product format: 804250589
Labeler code: 80425
Product ID: 80425-0589_5648d29c-cb17-98a3-e063-6294a90a0f11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA217400
Marketing category: ANDA
Marketing start: 2026-07-10
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: 2027-12-31
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
A217400-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2024-08-06
A217400-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2024-08-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217400-001	AB
A217400-002	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217400-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2024-08-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217400-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2024-08-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217400-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217400-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217400-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217400-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217400-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217400-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217400-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217400-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217400-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217400-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217400-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217400-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217400-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217400-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217400-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217400-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217400-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217400-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217400-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217400-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217400-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217400-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217400-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217400-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217400-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217400-002	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217400-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217400-002	AB	1	`a50c72e98297…`

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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
5648ca13-1add-56ec-e063-6294a90a6f29	Available on FDA.report

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	REMEDYREPACK INC.	669fbd46-cae5-4477-884e-8eca893d2e05	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	cd95271c-cf39-47fb-97a6-f6ee1e619e4a	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400
Famotidine	FAMOTIDINE	Advanced Rx of Tennessee, LLC	5648ca13-1add-56ec-e063-6294a90a6f29	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400 ndc (package): 80425-0589-3 ndc (product): 80425-0589 ndc11 (package): 80425058903
Famotidine	FAMOTIDINE	REMEDYREPACK INC.	8dbf43e0-856f-443b-b8a4-c69e006878ea	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400
Famotidine	FAMOTIDINE	Redpharm Drug	44f3f63d-4522-91e4-e063-6394a90a6d1b	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400
Famotidine	FAMOTIDINE	Novadoz Pharmaceuticals LLC	74a24590-a0b6-4607-8e67-9fadce53389b	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	c133a9e1-ca48-4ee2-8768-01f44f5dd511	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	6edbd842-cf86-48a5-bc22-967620a2b5cb	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217400 application number: ANDA217400

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	Marketing start	Sample	Exclude flag	Status
80425-0589-3	80425058903	90 TABLET, FILM COATED in 1 BOTTLE (80425-0589-3)	2026-07-10	No	No	Current