Famotidine

Product NDC: 70710-1684
11-digit product format: 707101684
Labeler code: 70710
Product ID: 70710-1684_5a3e9c70-b8f8-4866-b128-9f50272c03c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA216441
Marketing category: ANDA
Marketing start: 2022-06-06
Substance: FAMOTIDINE
Active strength: 40 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
A216441-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2022-06-03
A216441-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2022-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216441-001	AB
A216441-002	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 · 62 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	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 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	A216441-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216441-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216441-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216441-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216441-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216441-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216441-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216441-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216441-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216441-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216441-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216441-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216441-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216441-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216441-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216441-002	AB	1	`ea1830bbd6c7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Famotidine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	40 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
284245	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
b165979b-7ed0-423e-9aeb-2e061df0cd45	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70710-1684-0	Famotidine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2
70710-1684-1	Famotidine	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
70710-1684-2	Famotidine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	2
70710-1684-3	Famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
70710-1684-4	Famotidine	10 in 1 CARTON	TABLET, FILM COATED	10	2
70710-1684-5	Famotidine	500 in 1 BOTTLE	TABLET, FILM COATED	500	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1684-0	EA - Each	70710-1684	d8d62b14-b7e9-4404-8adb-3ce0ac082a3d	1	2022-07-06
70710-1684-1	EA - Each	70710-1684	08d5da86-6ab6-48a7-b00c-976959c0accf	1	2022-07-06
70710-1684-5	EA - Each	70710-1684	ac073ac9-04b3-4258-8f27-54f9af245950	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1684	FAMOTIDINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	2	Current NDC, Legacy NDC, 6 package rows	20231011_b165979b-7ed0-423e-9aeb-2e061df0cd45.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Safecor Health, LLC	1b5cb132-d28f-4fbe-91f5-dc04f9a551d1	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	St. Mary's Medical Park Pharmacy	f175822d-7ca4-fa33-e053-2995a90ac310	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	0786d7f5-85a7-d835-e063-6394a90ad719	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	Zydus Lifesciences Limited	8c17f9e3-9827-4bf9-85ca-72e08a8518ca	2024-11-30		Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	72a97532-9a79-4cbf-b9d0-22ce1f21468d	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	8dc075fe-a3e5-4710-8c19-73558a8c5f09	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441
Famotidine	FAMOTIDINE	Zydus Pharmaceuticals USA Inc.	b165979b-7ed0-423e-9aeb-2e061df0cd45	2023-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216441 application number: ANDA216441 ndc (product): 70710-1684

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
284245	famotidine 40 MG Oral Tablet	PSN	8dc075fe-a3e5-4710-8c19-73558a8c5f09	102
284245	famotidine 40 MG Oral Tablet	SCD	8dc075fe-a3e5-4710-8c19-73558a8c5f09	102
284245	famotidine 40 MG Oral Tablet	PSN	0786d7f5-85a7-d835-e063-6394a90ad719	3
284245	famotidine 40 MG Oral Tablet	SCD	0786d7f5-85a7-d835-e063-6394a90ad719	3
310273	famotidine 20 MG Oral Tablet	PSN	b165979b-7ed0-423e-9aeb-2e061df0cd45	2
284245	famotidine 40 MG Oral Tablet	PSN	b165979b-7ed0-423e-9aeb-2e061df0cd45	2
284245	famotidine 40 MG Oral Tablet	PSN	f175822d-7ca4-fa33-e053-2995a90ac310	2
310273	famotidine 20 MG Oral Tablet	SCD	b165979b-7ed0-423e-9aeb-2e061df0cd45	2
284245	famotidine 40 MG Oral Tablet	SCD	b165979b-7ed0-423e-9aeb-2e061df0cd45	2
284245	famotidine 40 MG Oral Tablet	SCD	f175822d-7ca4-fa33-e053-2995a90ac310	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70710-1684-0	70710168400	1000 TABLET, FILM COATED in 1 BOTTLE (70710-1684-0)		2022-06-06	0000-00-00	No	No	Current
70710-1684-1	70710168401	100 TABLET, FILM COATED in 1 BOTTLE (70710-1684-1)		2022-06-06	0000-00-00	No	No	Current
70710-1684-2	70710168402	10 in 1 BLISTER PACK						Historical
70710-1684-3	70710168403	30 TABLET, FILM COATED in 1 BOTTLE (70710-1684-3)		2022-06-06	0000-00-00	No	No	Current
70710-1684-4	70710168404	10 BLISTER PACK in 1 CARTON (70710-1684-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1684-2)	10 blister pack	2022-06-06	0000-00-00	No	No	Current
70710-1684-5	70710168405	500 TABLET, FILM COATED in 1 BOTTLE (70710-1684-5)		2022-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine	St. Mary's Medical Park Pharmacy	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	3
Famotidine	NuCare Pharmaceuticals,Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	3
Famotidine	Bryant Ranch Prepack	2024-08-23	HUMAN PRESCRIPTION DRUG LABEL	102
Famotidine	Preferred Pharmaceuticals Inc.	2024-04-23	HUMAN PRESCRIPTION DRUG LABEL	3
Famotidine	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-10-06	HUMAN PRESCRIPTION DRUG LABEL	2