Famotidine

Product NDC: 46122-168
11-digit product format: 461220168
Labeler code: 46122
Product ID: 46122-168_e5f19576-19b4-4edd-ba10-567a8b062f4d
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AMERISOURCE BERGEN
Application: ANDA090283
Marketing category: ANDA
Marketing start: 2013-05-01
Marketing end: 0000-00-00
Substance: FAMOTIDINE
Active strength: 20 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	46122-168		I	Inactivated by FDA		2026-08-03
excluded package	package	46122-168	46122-168-78	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46122-168-78	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46122-168-78	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46122-168-78	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46122-168-78	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46122-168-78	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46122-168-78	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46122-168-78	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46122-168-78	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46122-168-78	U	Excluded because listing certification expired	`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
A090283-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2009-11-17
A090283-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2009-11-17

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46122-168-78	2025-01-30	C162847	48780-1	2cef2736-704d-d83d-e063-dadaa90ab31f	Famotidine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-168-78	Famotidine	100 in 1 BOTTLE	TABLET, FILM COATED	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-168-78	EA - Each	46122-168	97ffac12-41d9-439d-b0ac-0a6188ec301e	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-168	FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]	3	Legacy NDC, 1 package rows	20190724_1a43eb84-da0b-4c06-ba0d-e4a469ecaa6a.zip

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	1a43eb84-da0b-4c06-ba0d-e4a469ecaa6a	3
310273	famotidine 20 MG Oral Tablet	SCD	1a43eb84-da0b-4c06-ba0d-e4a469ecaa6a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-168-78	46122016878	100 TABLET, FILM COATED in 1 BOTTLE (46122-168-78)	2013-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine	AMERISOURCE BERGEN \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2019-07-22	HUMAN OTC DRUG LABEL	3