Famotidine

Product NDC: 67296-1383
11-digit product format: 672961383
Labeler code: 67296
Product ID: 67296-1383_d61fb787-346d-52ac-e053-2995a90a80a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA078916
Marketing category: ANDA
Marketing start: 2016-01-29
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-1383		I	Inactivated by FDA		2026-08-03
excluded package	package	67296-1383	67296-1383-3	I	Inactivated by FDA		2026-08-03

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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1383-3	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1383-3	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1383-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1383-3	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1383-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A078916-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2009-05-22
A078916-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2009-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078916-001	AB
A078916-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078916-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2009-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078916-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2009-05-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078916-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078916-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078916-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078916-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078916-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078916-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078916-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078916-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078916-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078916-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078916-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078916-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078916-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078916-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078916-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078916-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078916-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078916-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078916-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078916-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078916-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078916-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078916-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078916-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078916-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078916-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078916-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078916-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078916-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078916-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078916-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078916-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078916-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078916-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078916-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078916-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078916-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078916-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078916-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078916-002	AB	1	`782e0a99824c…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
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
67296-1383-3	2024-07-18	C162847	48780-1	1030e365-167f-111a-e063-dadaa90a10e2	50597369-cb08-5a5b-e054-00144ff88e88
67296-1383-3	2024-01-30	C162847	48780-1	1030e365-167f-111a-e063-dadaa90a10e2	50597369-cb08-5a5b-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1383-3	Famotidine	30 in 1 BOTTLE	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1383	FAMOTIDINE TABLET [REDPHARM DRUG, INC.]	5	Legacy NDC, 1 package rows	20240719_50597369-cb08-5a5b-e054-00144ff88e88.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	32fd4101-15cb-411e-8b9d-270ec0592c6e	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	cf2cd30e-9a0f-4b63-975c-5b551691cda9	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	db3af7cc-efc6-4934-acff-8bb2d31fe829	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Alembic Pharmaceuticals Inc.	f149ecc1-d66c-42f9-a3f4-2ab6a522942b	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	43454e0f-4e1e-bbc6-e063-6394a90a5ac4	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	NCS HealthCare of KY, LLC dba Vangard Labs	59b17677-d805-4d9e-9c64-96385ae47bff	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
FAMOTIDINE	FAMOTIDINE	direct rx	b1b82d2a-cdb5-3e22-e053-2995a90a917d	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Alembic Pharmaceuticals Limited	7c0f3fa5-0a44-4a98-bc43-8bff8e95c462	2024-10-31	Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals, Inc.	4b820924-24ad-4a2f-e054-00144ff88e88	2024-07-19	Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Proficient Rx LP	9baf2596-b771-4bae-a03c-d3af6716821d	2022-05-02	Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Aphena Pharma Solutions - Tennessee, LLC	b1839d23-20f4-4651-a7d2-8bc3a7583917	2020-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916
Famotidine	FAMOTIDINE	Proficient Rx LP	92048836-e692-4ce1-93f4-88b00acabcde	2019-11-01	Adverse reactions	Exact identifier application applno (ANDA): 078916 application number: ANDA078916

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	50597369-cb08-5a5b-e054-00144ff88e88	5
310273	famotidine 20 MG Oral Tablet	SCD	50597369-cb08-5a5b-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1383-3	67296138303	30 TABLET in 1 BOTTLE (67296-1383-3)	30 tablet	2016-01-29	0000-00-00	No	No	Current