Famotidine

Product NDC: 68788-9220
11-digit product format: 687889220
Labeler code: 68788
Product ID: 68788-9220_f03eeec0-c902-4624-8dc1-f260ede48ca4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA075718
Marketing category: ANDA
Marketing start: 2001-04-16
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: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9220		D	Discontinued by firm	2026-08-03
excluded package	package	68788-9220	68788-9220-1	D	Discontinued by firm	2026-08-03
excluded package	package	68788-9220	68788-9220-3	D	Discontinued by firm	2026-08-03
excluded package	package	68788-9220	68788-9220-6	D	Discontinued by firm	2026-08-03
excluded package	package	68788-9220	68788-9220-8	D	Discontinued by firm	2026-08-03
excluded package	package	68788-9220	68788-9220-9	D	Discontinued by firm	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 2 · 78 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	68788-9220-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9220-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9220-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9220-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9220-8	`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	68788-9220-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9220-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9220-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9220-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9220-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9220-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9220-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9220-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9220-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9220-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9220-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9220-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9220-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9220-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9220-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9220-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9220-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9220-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9220-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9220-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9220-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9220-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9220-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9220-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9220-8	`cdf11ea48f46…`	`ba0047e9e063…`
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	68788-9220-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9220-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9220-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9220-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9220-8	`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	68788-9220-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9220-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9220-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9220-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9220-8	`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	68788-9220-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9220-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9220-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9220-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9220-8	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9220-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9220-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9220-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9220-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9220-8	`ad56d346431e…`	`cc804d4bbf1e…`

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
A075718-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075718-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075718-001	AB
A075718-002	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	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`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	A075718-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075718-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075718-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075718-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075718-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075718-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075718-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075718-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075718-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075718-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075718-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075718-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075718-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075718-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075718-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075718-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075718-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075718-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68788-9220-1	2020-11-10	Famotidine Tablets 20mg
68788-9220-3	2020-11-10	Famotidine Tablets 20mg
68788-9220-6	2020-11-10	Famotidine Tablets 20mg
68788-9220-8	2020-11-10	Famotidine Tablets 20mg
68788-9220-9	2020-11-10	Famotidine Tablets 20mg
68788-9220-1	2020-01-31	Famotidine Tablets 20mg
68788-9220-3	2020-01-31	Famotidine Tablets 20mg
68788-9220-6	2020-01-31	Famotidine Tablets 20mg
68788-9220-8	2020-01-31	Famotidine Tablets 20mg
68788-9220-9	2020-01-31	Famotidine Tablets 20mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
famotidine	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
famotidine	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	3

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	Sportpharm LLC	4421ceb7-a114-436c-871a-7bc5444f8154	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Proficient Rx LP	68d21d95-9603-4e68-855a-bfc65b1b58c3	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	5d515c2a-dac9-42d8-aede-66d28a427dbc	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	cdd5dfb7-4efb-4235-8023-5ce145c09038	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	545d5c1f-ec1c-4135-965f-333ad888d96f	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Legacy Pharmaceutical Packaging, LLC	cc88fbdc-546e-332f-e053-2995a90a8ca7	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	5ed77259-5dd9-4634-a073-346693488c4f	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Major Pharmaceuticals	3e6d167f-91e4-4122-911d-d3da66386f44	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	AvPAK	dfdca61d-8824-6230-e053-2995a90a209d	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Quality Care Products, LLC	3549386a-533d-4e44-8097-f6bc51ee494a	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Direct_Rx	138d9ed1-2f8f-d19d-e063-6394a90a695d	2024-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Dr.Reddy's Laboratories Limited	06d286ce-14b3-4b66-8b42-ac4a10a0fc90	2020-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine Tablets 20mg	Preferred Pharmaceuticals, Inc.	2018-05-22	HUMAN PRESCRIPTION DRUG LABEL	5