Famotidine

Product NDC: 70860-751
Requested package NDC: 70860-751-02
11-digit product format: 708600751
Labeler code: 70860
Product ID: 70860-751_2cc9707d-b7b9-36ec-e063-6294a90a1e44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: famotidine
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA075622
Marketing category: ANDA
Marketing start: 2020-08-10
Marketing end: 2026-07-31
Substance: FAMOTIDINE
Active strength: 10 mg/mL
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-751	70860-751-02	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075622-001	FAMOTIDINE PRESERVATIVE FREE	FAMOTIDINE	10MG/ML	INJECTABLE / INJECTION	AP		2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075622-001	AP

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075622-001	FAMOTIDINE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2001-04-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075622-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075622-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075622-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075622-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075622-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075622-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075622-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075622-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075622-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075622-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075622-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075622-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075622-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075622-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075622-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075622-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075622-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075622-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075622-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075622-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075622-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075622-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075622-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075622-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075622-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075622-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075622-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075622-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075622-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075622-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075622-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075622-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075622-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075622-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075622-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075622-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075622-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075622-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075622-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075622-001	AP	1	`cb3db0bc1861…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-751-02	2024-03-03	C162847	48780-1	1030e364-fdf0-111a-e063-dadaa90a10e2	Famotidine Injection, USP
70860-751-02	2024-01-30	C162847	48780-1	1030e364-fdf0-111a-e063-dadaa90a10e2	Famotidine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70860-751-02	Famotidine	25 in 1 CARTON	INJECTION, SOLUTION	25		5
70860-751-41	Famotidine	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-751-02	ML - Milliliter	70860-751	96e7acb3-a44a-40e4-a071-c36d59631905	1	2021-01-08
70860-751-41	ML - Milliliter	70860-751	bed63e24-a456-4e67-83ab-2b70d1a87c3d	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70860-751	FAMOTIDINE INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]	5	Current NDC, Legacy NDC, 2 package rows	20250130_234d941f-5754-4d83-b02e-26638e0054e6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Medical Purchasing Solutions, LLC	4e803491-8030-50d0-e063-6294a90a5c8d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075622 application number: ANDA075622
Famotidine	FAMOTIDINE	Sagent Pharmaceuticals	2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c958	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075622 application number: ANDA075622

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
204441	famotidine 10 MG/ML Injectable Solution	PSN	234d941f-5754-4d83-b02e-26638e0054e6	5
1743833	famotidine 20 MG in 2 ML Injection	PSN	234d941f-5754-4d83-b02e-26638e0054e6	5
1743833	2 ML famotidine 10 MG/ML Injection	SCD	234d941f-5754-4d83-b02e-26638e0054e6	5
204441	famotidine 10 MG/ML Injectable Solution	SCD	234d941f-5754-4d83-b02e-26638e0054e6	5
1743833	famotidine 20 MG per 2 ML Injection	SY	234d941f-5754-4d83-b02e-26638e0054e6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-751-02	70860075102	25 VIAL, SINGLE-DOSE in 1 CARTON (70860-751-02) / 2 mL in 1 VIAL, SINGLE-DOSE (70860-751-41)	2020-08-10	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine Injection, USP	Athenex Pharmaceutical Division, LLC.	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	5