FAMOTIDINE

Product NDC: 70518-4574
Requested package NDC: 70518-4574-1
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 43.

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.

Product history page 1 of 2 · 68 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
2026-09-14 22:38:34	2026-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215630-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215630-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215630-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215630-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215630-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215630-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215630-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215630-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215630-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215630-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215630-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215630-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215630-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215630-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215630-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215630-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215630-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215630-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	9c5dce17-1865-4aa6-89f6-24dd55b5f06c	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
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): 70518-4574-1 ndc (product): 70518-4574 ndc11 (package): 70518457401
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

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
70518-4574-1	70518457401	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4574-1)	2026-03-04	No	No	Current