Famotidine

Product NDC: 68788-7191
11-digit product format: 687887191
Labeler code: 68788
Product ID: 68788-7191_f6ba3cb2-49cc-41ce-a2fb-d909398dce55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA078916
Marketing category: ANDA
Marketing start: 2018-07-18
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7191		D	Discontinued by firm	2026-08-07
excluded package	package	68788-7191	68788-7191-1	D	Discontinued by firm	2026-08-07
excluded package	package	68788-7191	68788-7191-3	D	Discontinued by firm	2026-08-07
excluded package	package	68788-7191	68788-7191-4	D	Discontinued by firm	2026-08-07
excluded package	package	68788-7191	68788-7191-6	D	Discontinued by firm	2026-08-07
excluded package	package	68788-7191	68788-7191-8	D	Discontinued by firm	2026-08-07
excluded package	package	68788-7191	68788-7191-9	D	Discontinued by firm	2026-08-07

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 · 14 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7191-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7191-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7191-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7191-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7191-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7191-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7191-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7191-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7191-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7191-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7191-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7191-9	`f5e01cc5f278…`	`a2eaf40c39c3…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7191-1	EA - Each	68788-7191	e0325d7f-8b84-4348-8348-58d2aab9687d	1	2018-09-05
68788-7191-3	EA - Each	68788-7191	b24d6893-aa52-464b-b491-9bf7c403a6ec	1	2018-09-05
68788-7191-4	EA - Each	68788-7191	04f00cb0-deb7-4f2d-ae2b-b84376e98b2a	1	2018-09-05
68788-7191-6	EA - Each	68788-7191	6a2017e2-2ef1-4be9-94ad-7372149847f8	1	2018-09-05
68788-7191-8	EA - Each	68788-7191	0a45c1ff-4c5a-453f-9892-d81666cf04e3	1	2018-09-05
68788-7191-9	EA - Each	68788-7191	45873735-dabc-42bc-a1f2-0f4c72c06a89	1	2018-09-05

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7191-1	68788719101	100 TABLET in 1 BOTTLE (68788-7191-1)	100 tablet	2018-07-18	0000-00-00	No	No	Current
68788-7191-3	68788719103	30 TABLET in 1 BOTTLE (68788-7191-3)	30 tablet	2018-07-18	0000-00-00	No	No	Current
68788-7191-4	68788719104	14 TABLET in 1 BOTTLE (68788-7191-4)	14 tablet	2018-07-18	0000-00-00	No	No	Current
68788-7191-6	68788719106	60 TABLET in 1 BOTTLE (68788-7191-6)	60 tablet	2018-07-18	0000-00-00	No	No	Current
68788-7191-8	68788719108	120 TABLET in 1 BOTTLE (68788-7191-8)	120 tablet	2018-07-18	0000-00-00	No	No	Current
68788-7191-9	68788719109	90 TABLET in 1 BOTTLE (68788-7191-9)	90 tablet	2018-07-18	0000-00-00	No	No	Current