Famotidine

Product NDC: 80425-0329
Requested package NDC: 80425-0329-3
11-digit product format: 804250329
Labeler code: 80425
Product ID: 80425-0329_2a9c0c91-2b34-4def-e063-6294a90a58ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA215767
Marketing category: ANDA
Marketing start: 2023-04-24
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 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
A215767-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2021-11-04
A215767-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2021-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215767-001	AB
A215767-002	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 · 70 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	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215767-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2021-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215767-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2021-11-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A215767-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215767-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215767-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215767-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215767-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215767-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215767-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215767-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215767-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215767-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215767-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215767-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215767-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215767-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215767-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215767-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215767-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215767-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215767-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215767-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215767-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215767-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215767-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215767-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215767-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215767-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215767-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215767-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215767-002	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: 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
fa18ed52-f038-02dd-e053-6394a90ac946	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
80425-0329-1	Famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
80425-0329-2	Famotidine	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
80425-0329-3	Famotidine	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0329-1	EA - Each	80425-0329	0cc68a21-b01f-429f-9086-d78b7fbf45f5	1	2023-06-06
80425-0329-2	EA - Each	80425-0329	0fc519ef-64eb-49d5-92ce-8a03006dbe47	1	2024-06-10
80425-0329-3	EA - Each	80425-0329	f5383420-4305-45d1-a32a-a69a86bbc454	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0329	FAMOTIDINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 3 package rows	20250102_fa18ed52-f038-02dd-e053-6394a90ac946.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	599642c8-51cd-4220-e063-6394a90a5e20	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Redpharm Drug	55730918-d9e8-eaad-e063-6394a90aeda2	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	ST. MARY'S MEDICAL PARK PHARMACY	31cdc900-fe17-2d5f-e063-6294a90a0fda	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals, Inc.	b1edf3c5-e42c-471b-8771-6c93094822de	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	002875d2-8c30-2d2e-e063-6294a90ae01e	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	2f5ec69d-926c-47a2-be47-8fef2e0ff207	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	e034546b-28cb-41aa-9441-655cdb966554	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Advanced Rx Pharmacy of Tennessee, LLC	fa18ed52-f038-02dd-e053-6394a90ac946	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767 ndc (package): 80425-0329-3 ndc (product): 80425-0329 ndc11 (package): 80425032903
Acid Reducer	FAMOTIDINE	Allegiant Health	5c6c6665-cb0a-41d1-af28-85b4f061bd1b	2024-10-30	Warnings	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	66878006-8913-4c91-8038-901142cf520d	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	0abfc8e6-7fdf-4828-89f4-2202002f8489	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	75a334ee-48b9-47e7-8225-6e595bed8a74	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	A-S Medication Solutions	99de67a5-a566-46c9-bc80-dc6fc03be11f	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767
Famotidine	FAMOTIDINE	Camber Pharmaceuticals, Inc.	902b5d4b-1707-4312-9f46-ef5ab86b00f0	2021-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215767 application number: ANDA215767

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	fa18ed52-f038-02dd-e053-6394a90ac946	2
310273	famotidine 20 MG Oral Tablet	SCD	fa18ed52-f038-02dd-e053-6394a90ac946	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0329-3	80425032903	90 TABLET, FILM COATED in 1 BOTTLE (80425-0329-3)	2023-04-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine Tablet	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2