Famotidine

Product NDC: 68071-3521
11-digit product format: 680713521
Labeler code: 68071
Product ID: 68071-3521_2d3f8242-1bd2-44b6-e063-6394a90a1a32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA216441
Marketing category: ANDA
Marketing start: 2022-06-06
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3521-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3521-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3521-3	`0efc9e666f02…`	`f202fb6c5f17…`

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
A216441-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2022-06-03
A216441-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2022-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216441-001	AB
A216441-002	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.

Product history page 1 of 2 · 62 observed 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	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216441-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216441-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216441-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216441-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216441-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216441-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216441-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216441-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216441-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216441-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216441-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216441-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216441-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216441-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216441-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216441-002	AB	1	`ea1830bbd6c7…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
284245	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
0786d7f5-85a7-d835-e063-6394a90ad719	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3521-3	2025-02-03	C162847	48780-1	2cef2736-8d93-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
68071-3521-3	2025-01-30	C162847	48780-1	2cef2736-8d93-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3521-3	Famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3521	FAMOTIDINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, 1 package rows	20250205_0786d7f5-85a7-d835-e063-6394a90ad719.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Safecor Health, LLC	1b5cb132-d28f-4fbe-91f5-dc04f9a551d1	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	St. Mary's Medical Park Pharmacy	f175822d-7ca4-fa33-e053-2995a90ac310	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	0786d7f5-85a7-d835-e063-6394a90ad719	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441 ndc (product): 68071-3521
Famotidine	FAMOTIDINE	Zydus Lifesciences Limited	8c17f9e3-9827-4bf9-85ca-72e08a8518ca	2024-11-30		Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	72a97532-9a79-4cbf-b9d0-22ce1f21468d	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	8dc075fe-a3e5-4710-8c19-73558a8c5f09	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	Zydus Pharmaceuticals USA Inc.	b165979b-7ed0-423e-9aeb-2e061df0cd45	2023-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441

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
284245	famotidine 40 MG Oral Tablet	PSN	0786d7f5-85a7-d835-e063-6394a90ad719	3
284245	famotidine 40 MG Oral Tablet	SCD	0786d7f5-85a7-d835-e063-6394a90ad719	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3521-3	68071352103	30 TABLET, FILM COATED in 1 BOTTLE (68071-3521-3)	2023-10-12	No	No	Current