Famotidine

Product NDC: 63739-645
11-digit product format: 637390645
Labeler code: 63739
Product ID: 63739-645_e289f8ab-e94f-0e6b-e053-2a95a90aa683
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Mckesson Corporation DBA SKY Packaginng
Application: ANDA075805
Marketing category: ANDA
Marketing start: 2001-04-16
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-645		D	Discontinued by firm		2026-08-03
excluded package	package	63739-645	63739-645-10	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075805-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075805-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075805-001	AB
A075805-002	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 3 · 82 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	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075805-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075805-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075805-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075805-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075805-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075805-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075805-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075805-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075805-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075805-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075805-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075805-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075805-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075805-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075805-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075805-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075805-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075805-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075805-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075805-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075805-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075805-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075805-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075805-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075805-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075805-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075805-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075805-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075805-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075805-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075805-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-645-10	2020-07-22	C162847	48780-1	ab0e2407-2fa5-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use Famotidine Tablets safely and effectively. See full prescribing information for Famotidine Tablets. Famotidine tablets, for oral use Initial U.S. Approval: 1986
63739-645-41	2020-07-22	C162847	48780-1	ab0e2407-2fa5-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use Famotidine Tablets safely and effectively. See full prescribing information for Famotidine Tablets. Famotidine tablets, for oral use Initial U.S. Approval: 1986

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-645-10	EA - Each	63739-645	fb4091b8-3ff3-42e3-8f56-ba8e8c818b11	1	2015-02-02
63739-645-41	EA - Each	63739-645	64c6764d-78ea-42f6-8b1a-dc640621196e	1	2019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Famotidine	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
Famotidine	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-645	FAMOTIDINE TABLET [MCKESSON CORPORATION DBA SKY PACKAGINNG]	16	Legacy NDC	20241222_510a7cd1-52eb-40b0-a7f1-81bebf9ae2a6.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	A-S Medication Solutions	d0558e97-3bc3-4a1e-9248-1959b0344023	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	ab1cdbbf-d838-020c-e053-2995a90a0f65	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	AvPAK	85c7d20d-3dec-b918-4c1d-8ca1db214e48	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	66f0bf15-ff35-426a-b40c-0d0da79d0861	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	09ef39a4-c6b3-4395-8211-3f551dc44830	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
FAMOTIDINE	FAMOTIDINE	direct rx	c3de241e-6217-d6e0-e053-2a95a90a35c5	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Golden State Medical Supply, Inc.	f67bcbc7-952c-61c0-e053-2a95a90a6fa6	2024-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	67a6e7f3-04d6-426c-b952-7677a84ace4d	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	92a75aa6-3c63-4c98-be8e-dcd03affc10b	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	81f24752-3474-3013-0013-5570c8e7baf7	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	82930f64-4556-491f-96cc-270be9e3589a	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Carlsbad Technology, Inc	a8b5c855-053d-4295-8f57-1a96a6ccaa92	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	b556d1a8-4155-50cf-e053-2995a90a9b14	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	60cd0973-f74e-2b70-e053-2a91aa0a4361	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Pepcid	FAMOTIDINE	Bausch Health US LLC	a06502d9-7903-4f37-833e-e5763d502def	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	A-S Medication Solutions	ae3646c7-76fc-473d-b20b-67d3c6ac0b75	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Proficient Rx LP	c84b0ba3-1ba8-4da9-b5b8-186e01cda999	2022-07-01	Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Aphena Pharma Solutions - Tennessee, LLC	46c6d243-eefc-40ca-8bd4-4c89456f635f	2021-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805
Famotidine	FAMOTIDINE	Proficient Rx LP	1e2003d4-09a3-4cc8-af3d-93d29b9123c0	2020-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075805 application number: ANDA075805

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-645-10	63739064510	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-645-10) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2015-01-29	0000-00-00	No	No	Current
63739-645-41	63739064541	30 TABLET in 1 BOTTLE (63739-645-41)	30 tablet	2019-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine	Cardinal Health 107, LLC	2025-06-24	HUMAN PRESCRIPTION DRUG LABEL	8
Famotidine	Mckesson Corporation DBA SKY Packaginng	2024-12-20	HUMAN PRESCRIPTION DRUG LABEL	16