FAMOTIDINE

Product NDC: 72189-141
11-digit product format: 721890141
Labeler code: 72189
Product ID: 72189-141_2be91ea1-1f27-d635-e063-6294a90a4dd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FAMOTIDINE
Dosage form: TABLET
Route: ORAL
Labeler: direct rx
Application: ANDA078916
Marketing category: ANDA
Marketing start: 2020-10-15
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: 2026-12-31
Current FDA listing: Yes

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 · 3 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	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	72189-141		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-141	72189-141-90	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-141	72189-141-60	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: FAMOTIDINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QZO15J2Z8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310273	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b1b82d2a-cdb5-3e22-e053-2995a90a917d	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-141-60	FAMOTIDINE	60 in 1 BOTTLE	TABLET	60		3
72189-141-90	FAMOTIDINE	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-141-90	EA - Each	72189-141	22fd7fbf-a573-4e05-ba24-883c46b63468	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-141	FAMOTIDINE TABLET [DIRECT RX]	3	Current NDC, Legacy NDC, 2 package rows	20250119_b1b82d2a-cdb5-3e22-e053-2995a90a917d.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 ndc (product): 72189-141
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	b1b82d2a-cdb5-3e22-e053-2995a90a917d	3
310273	famotidine 20 MG Oral Tablet	SCD	b1b82d2a-cdb5-3e22-e053-2995a90a917d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-141-60	72189014160	60 TABLET in 1 BOTTLE (72189-141-60)	60 tablet	2020-10-15	0000-00-00	No	No	Current
72189-141-90	72189014190	90 TABLET in 1 BOTTLE (72189-141-90)	90 tablet	2020-10-15	0000-00-00	No	No	Current