Famotidine

Product NDC: 45865-881
Requested package NDC: 45865-881-60
11-digit product format: 458650881
Labeler code: 45865
Product ID: 45865-881_9ab48913-6850-9988-e053-2995a90afeb2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA075511
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45865-881	45865-881-60	I	Inactivated by FDA		2026-08-03

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
A075511-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075511-002	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
A075511-001	AB
A075511-002	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	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075511-002	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	A075511-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075511-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075511-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075511-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075511-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075511-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075511-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075511-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075511-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075511-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075511-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075511-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075511-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075511-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075511-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075511-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075511-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075511-002	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
45865-881-51	2024-02-29	Famotidine Tablets USP Rx only
45865-881-60	2024-02-29	Famotidine Tablets USP Rx only
45865-881-51	2023-01-30	Famotidine Tablets USP Rx only
45865-881-60	2023-01-30	Famotidine Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-881-51	Famotidine	120 in 1 BOTTLE	TABLET, FILM COATED	120		3
45865-881-60	Famotidine	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-881	FAMOTIDINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	3	Legacy NDC, 2 package rows	20240302_7dc845a4-d0dd-41c5-e053-2a91aa0ae5b3.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Proficient Rx LP	d60bde93-f512-4071-9e4b-1d8318def3bc	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	f2b6da72-72ea-d81b-e053-2995a90a9526	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	03503cd5-bd8e-4bff-b90d-1a71c5225b91	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	5798d282-ce83-49aa-bc33-13203f2b5285	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	A-S Medication Solutions	2bde8e1d-078f-4ba1-9ccb-29de6e36d8c4	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	A-S Medication Solutions	74ff64f2-d882-411f-bac8-29dfa4cb4f10	2023-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Proficient Rx LP	fe21daca-ac48-4b46-9cb3-9a69af0c6a84	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Teva Pharmaceuticals USA, Inc.	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	2019-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511

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	7dc845a4-d0dd-41c5-e053-2a91aa0ae5b3	3
310273	famotidine 20 MG Oral Tablet	SCD	7dc845a4-d0dd-41c5-e053-2a91aa0ae5b3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-881-60	45865088160	60 TABLET, FILM COATED in 1 BOTTLE (45865-881-60)	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine Tablets USP Rx only	Medsource Pharmaceuticals	2024-02-29	HUMAN PRESCRIPTION DRUG LABEL	3