FAMOTIDINE

Product NDC: 43602-602
11-digit product format: 436020602
Labeler code: 43602
Product ID: 43602-602_a2adad08-283e-4617-b3db-1eade7f5b296
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Ascent Pharmaceuticals, Inc.
Application: ANDA216030
Marketing category: ANDA
Marketing start: 2021-11-03
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216030-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2021-11-03
A216030-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2021-11-03

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 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A216030-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A216030-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-03	`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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199047	Internal RxNorm lookup
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
b481dd30-7d64-43ec-85d4-2289db62cad7	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
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43602-602-03	FAMOTIDINE	1 in 1 CARTON	TABLET	1	3
43602-602-03	FAMOTIDINE	300 in 1 BOTTLE	TABLET	300	3
43602-602-30	FAMOTIDINE	30 in 1 BOTTLE	TABLET	30	3
43602-602-30	FAMOTIDINE	1 in 1 CARTON	TABLET	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43602-602	FAMOTIDINE TABLET [ASCENT PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 4 package rows	20220218_b481dd30-7d64-43ec-85d4-2289db62cad7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	Ascent Pharmaceuticals, Inc.	b481dd30-7d64-43ec-85d4-2289db62cad7	2022-02-14	Warnings	Exact identifier application applno (ANDA): 216030 application number: ANDA216030 ndc (product): 43602-602

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
199047	famotidine 10 MG Oral Tablet	PSN	b481dd30-7d64-43ec-85d4-2289db62cad7	3
310273	famotidine 20 MG Oral Tablet	PSN	b481dd30-7d64-43ec-85d4-2289db62cad7	3
199047	famotidine 10 MG Oral Tablet	SCD	b481dd30-7d64-43ec-85d4-2289db62cad7	3
310273	famotidine 20 MG Oral Tablet	SCD	b481dd30-7d64-43ec-85d4-2289db62cad7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43602-602-03	43602060203	1 BOTTLE in 1 CARTON (43602-602-03) / 300 TABLET in 1 BOTTLE	1 bottle	2021-11-03	0000-00-00	No	No	Current
43602-602-30	43602060230	1 BOTTLE in 1 CARTON (43602-602-30) / 30 TABLET in 1 BOTTLE	1 bottle	2021-11-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FAMOTIDINE - Ascent Pharmaceuticals, Inc.	Ascent Pharmaceuticals, Inc.	2022-02-14	Human OTC Drug Label	3