Famotidine

Product NDC: 55154-6843
11-digit product format: 551546843
Labeler code: 55154
Product ID: 55154-6843_170da273-0764-4310-8654-f5f6007a7705
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA075805
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: 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	55154-6843		D	Discontinued by firm		2026-08-03
excluded package	package	55154-6843	55154-6843-0	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 1 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	55154-6843		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-6843	55154-6843-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A075805-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075805-002	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
A075805-001	AB
A075805-002	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	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075805-002	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	A075805-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075805-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075805-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075805-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075805-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075805-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075805-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075805-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075805-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075805-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075805-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075805-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075805-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075805-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075805-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075805-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075805-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075805-002	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
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-6843	FAMOTIDINE TABLET [CARDINAL HEALTH 107, LLC]	7	Legacy NDC	20240423_97615282-1f8a-4a95-af9a-82de0bda7d32.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	A-S Medication Solutions	d0558e97-3bc3-4a1e-9248-1959b0344023	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	ab1cdbbf-d838-020c-e053-2995a90a0f65	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	AvPAK	85c7d20d-3dec-b918-4c1d-8ca1db214e48	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	66f0bf15-ff35-426a-b40c-0d0da79d0861	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	09ef39a4-c6b3-4395-8211-3f551dc44830	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
FAMOTIDINE	FAMOTIDINE	direct rx	c3de241e-6217-d6e0-e053-2a95a90a35c5	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Golden State Medical Supply, Inc.	f67bcbc7-952c-61c0-e053-2a95a90a6fa6	2024-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	67a6e7f3-04d6-426c-b952-7677a84ace4d	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	92a75aa6-3c63-4c98-be8e-dcd03affc10b	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	81f24752-3474-3013-0013-5570c8e7baf7	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	82930f64-4556-491f-96cc-270be9e3589a	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Carlsbad Technology, Inc	a8b5c855-053d-4295-8f57-1a96a6ccaa92	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	b556d1a8-4155-50cf-e053-2995a90a9b14	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	60cd0973-f74e-2b70-e053-2a91aa0a4361	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Pepcid	FAMOTIDINE	Bausch Health US LLC	a06502d9-7903-4f37-833e-e5763d502def	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	A-S Medication Solutions	ae3646c7-76fc-473d-b20b-67d3c6ac0b75	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Proficient Rx LP	c84b0ba3-1ba8-4da9-b5b8-186e01cda999	2022-07-01	Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Aphena Pharma Solutions - Tennessee, LLC	46c6d243-eefc-40ca-8bd4-4c89456f635f	2021-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Proficient Rx LP	1e2003d4-09a3-4cc8-af3d-93d29b9123c0	2020-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805

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
55154-6843-0	55154684300	10 BLISTER PACK in 1 BAG (55154-6843-0) > 1 TABLET in 1 BLISTER PACK	10 blister pack	2015-01-29	0000-00-00	No	No	Current