Famotidine

Product NDC: 63629-2782
Requested package NDC: 63629-2782-2
11-digit product format: 636292782
Labeler code: 63629
Product ID: 63629-2782_2e1e4581-a001-42fd-98f1-91ce454823ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075805
Marketing category: ANDA
Marketing start: 2001-04-16
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-2782	63629-2782-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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…`

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
81f24752-3474-3013-0013-5570c8e7baf7	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-2782-1	2020-10-16	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-2	2020-10-16	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-3	2020-10-16	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-4	2020-10-16	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-5	2020-10-16	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-6	2020-10-16	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-1	2020-01-31	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-2	2020-01-31	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-3	2020-01-31	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-4	2020-01-31	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-5	2020-01-31	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets
63629-2782-6	2020-01-31	These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986 Famotidine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-2782-1	Famotidine	30 in 1 BOTTLE	TABLET	30	10
63629-2782-2	Famotidine	60 in 1 BOTTLE	TABLET	60	10
63629-2782-3	Famotidine	100 in 1 BOTTLE	TABLET	100	10
63629-2782-4	Famotidine	90 in 1 BOTTLE	TABLET	90	10
63629-2782-5	Famotidine	15 in 1 BOTTLE	TABLET	15	10
63629-2782-6	Famotidine	120 in 1 BOTTLE	TABLET	120	10
63629-2782-7	Famotidine	20 in 1 BOTTLE	TABLET	20	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2782-1	EA - Each	63629-2782	7b32f5c8-5bec-448f-bd61-e57fd2574d25	1	2012-07-24
63629-2782-2	EA - Each	63629-2782	260621be-d6cc-40ed-98f9-06affe7018e6	1	2012-07-24
63629-2782-3	EA - Each	63629-2782	2fa4a2d6-4f4c-4a7b-ba7b-cfd4f137fa14	1	2012-07-24
63629-2782-4	EA - Each	63629-2782	8b8309da-05a2-48e7-b15b-a8f7f5cc9611	1	2021-01-08
63629-2782-5	EA - Each	63629-2782	ddde91e8-0cb1-49d5-aa4e-1a242ff02855	1	2021-01-08
63629-2782-6	EA - Each	63629-2782	0d9cc486-6eae-473a-bdc7-ee76cd63234a	1	2021-01-08
63629-2782-7	EA - Each	63629-2782	67afdfdc-2466-4b5b-bd32-fb1155ca7d61	1	2024-10-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2782	FAMOTIDINE TABLET [BRYANT RANCH PREPACK]	10	Current NDC, Legacy NDC, 7 package rows	20240912_81f24752-3474-3013-0013-5570c8e7baf7.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 ndc (package): 63629-2782-2 ndc (product): 63629-2782 ndc11 (package): 63629278202
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	81f24752-3474-3013-0013-5570c8e7baf7	10
284245	famotidine 40 MG Oral Tablet	PSN	81f24752-3474-3013-0013-5570c8e7baf7	10
310273	famotidine 20 MG Oral Tablet	SCD	81f24752-3474-3013-0013-5570c8e7baf7	10
284245	famotidine 40 MG Oral Tablet	SCD	81f24752-3474-3013-0013-5570c8e7baf7	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2782-2	63629278202	60 TABLET in 1 BOTTLE (63629-2782-2)	60 tablet	2007-06-26	0000-00-00	No	No	Current