FAMOTIDINE

Product NDC: 70518-4574
Requested package NDC: 70518-4574-3
11-digit product format: 705184574
Labeler code: 70518
Product ID: 70518-4574_4e7dedbd-fe91-4c60-e063-6394a90aec7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FAMOTIDINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA215630
Marketing category: ANDA
Marketing start: 2026-02-16
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: 2027-12-31
Current FDA listing: Yes

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
A215630-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2022-01-07
A215630-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2022-01-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215630-001	AB
A215630-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2022-01-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB		2022-01-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A215630-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A215630-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a0f38398-4d34-4ecc-8a6a-37732adaaad3	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	HAWAII REPACK, INC.	eec89230-47fc-4139-a370-b4f9e225e8c0	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	e59a2c97-19c7-485c-bb1b-272ddb9ae053	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	e53928f3-5181-490b-acfb-be8d4cea60a9	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	ST. MARY'S MEDICAL PARK PHARMACY	febe39b1-9212-a281-e053-6394a90a1a9f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Preferred Pharmaceuticals Inc.	b445a613-eaa8-45e8-be1f-5848bfd1dd36	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Preferred Pharmaceuticals Inc.	dbf94314-3a34-4f03-80b1-296559b7d6a5	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	3ab235f4-da59-4a92-ad6b-c76cf3ecd985	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630 ndc (package): 70518-4574-3 ndc (product): 70518-4574 ndc11 (package): 70518457403
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	9c5dce17-1865-4aa6-89f6-24dd55b5f06c	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	74a69baa-a7c5-4e67-8db6-2ec39ab6cfe5	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	7cef62ab-1740-4d0f-b6ea-fda783e1c197	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	3c32f8e2-f54a-422d-9c25-68692ea09001	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a3b50576-cd40-4f7e-9506-bd0a61988424	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	be69d9f9-f4ad-4cfe-bab2-e07186b25c1e	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	a24e8f45-6ace-4a81-8005-c23a55dadd9a	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	NuCare Pharmceuticals,Inc.	fc603d56-6828-8c5e-e053-6394a90a35bd	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	077bb160-e616-4863-bdde-989140f99e1c	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	fd271deb-c748-bf26-e053-6294a90a11aa	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Asclemed USA, Inc.	69bd5340-298b-46ca-83c7-0b5ef233f9c5	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630

Additional Listing Data#

Finished product: Yes
Brand name base: FAMOTIDINE
Listing expiration: 2027-12-31

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
3ab235f4-da59-4a92-ad6b-c76cf3ecd985	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
70518-4574-0	FAMOTIDINE	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	5
70518-4574-1	FAMOTIDINE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	5
70518-4574-2	FAMOTIDINE	80 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	80	5
70518-4574-3	FAMOTIDINE	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	5

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	3ab235f4-da59-4a92-ad6b-c76cf3ecd985	5
310273	famotidine 20 MG Oral Tablet	SCD	3ab235f4-da59-4a92-ad6b-c76cf3ecd985	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4574-3	70518457403	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4574-3)	2026-04-02	No	No	Current