Famotidine

Product NDC: 69367-401
11-digit product format: 693670401
Labeler code: 69367
Product ID: 69367-401_497a1a19-03b2-4e3d-b5c7-0b94a29b9cc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: ANDA217669
Marketing category: ANDA
Marketing start: 2024-09-09
Substance: FAMOTIDINE
Active strength: 40 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 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
A217669-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2023-12-20
A217669-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2023-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217669-001	AB
A217669-002	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	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217669-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2023-12-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217669-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2023-12-20	`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	A217669-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217669-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217669-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217669-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217669-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217669-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217669-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217669-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217669-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217669-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217669-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217669-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217669-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217669-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217669-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217669-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217669-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217669-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217669-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217669-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217669-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217669-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217669-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217669-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217669-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217669-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217669-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217669-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217669-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217669-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217669-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217669-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217669-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217669-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217669-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217669-002	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217669-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217669-002	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	40 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
284245	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
c0e15f57-ab20-4030-b1d1-6aff33be7d76	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
69367-401-10	Famotidine	1000 in 1 BOTTLE, PLASTIC	TABLET, COATED	1000		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-401-10	EA - Each	69367-401	73eb9d76-2908-4dcd-a1c4-4848f0be71a0	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-401	FAMOTIDINE TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC]	5	Current NDC, 1 package rows	20250409_c0e15f57-ab20-4030-b1d1-6aff33be7d76.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
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	fd5d15b9-b1b5-48ef-ba41-8a43a7642e94	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217669 application number: ANDA217669
Famotidine	FAMOTIDINE	Proficient Rx LP	702dd4fa-4a78-454d-91c5-493894750f7b	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217669 application number: ANDA217669
Famotidine	FAMOTIDINE	Westminster Pharmaceuticals, LLC	c0e15f57-ab20-4030-b1d1-6aff33be7d76	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217669 application number: ANDA217669 ndc (product): 69367-401
Famotidine	FAMOTIDINE	Proficient Rx LP	c7327748-835b-44df-848f-8c620d327ce6	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217669 application number: ANDA217669
Famotidine	FAMOTIDINE	Contract Pharmacal Corp.	273deac8-c2b0-423f-8662-4f16d91df216	2024-07-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217669 application number: ANDA217669

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	c0e15f57-ab20-4030-b1d1-6aff33be7d76	5
284245	famotidine 40 MG Oral Tablet	PSN	c0e15f57-ab20-4030-b1d1-6aff33be7d76	5
310273	famotidine 20 MG Oral Tablet	SCD	c0e15f57-ab20-4030-b1d1-6aff33be7d76	5
284245	famotidine 40 MG Oral Tablet	SCD	c0e15f57-ab20-4030-b1d1-6aff33be7d76	5
310273	famotidine 20 MG Oral Tablet	PSN	c7327748-835b-44df-848f-8c620d327ce6	2
284245	famotidine 40 MG Oral Tablet	PSN	c7327748-835b-44df-848f-8c620d327ce6	2
310273	famotidine 20 MG Oral Tablet	SCD	c7327748-835b-44df-848f-8c620d327ce6	2
284245	famotidine 40 MG Oral Tablet	SCD	c7327748-835b-44df-848f-8c620d327ce6	2
284245	famotidine 40 MG Oral Tablet	PSN	702dd4fa-4a78-454d-91c5-493894750f7b	1
284245	famotidine 40 MG Oral Tablet	SCD	702dd4fa-4a78-454d-91c5-493894750f7b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69367-401-10	69367040110	1000 TABLET, COATED in 1 BOTTLE, PLASTIC (69367-401-10)	2024-09-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine	Proficient Rx LP	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	1
Famotidine	Westminster Pharmaceuticals, LLC \| Contract Pharmacal Corp.	2025-04-07	HUMAN PRESCRIPTION DRUG LABEL	5
Famotidine	Proficient Rx LP	2025-02-01	HUMAN PRESCRIPTION DRUG LABEL	2