Famotidine

Product NDC: 0172-5729
11-digit product format: 001725729
Labeler code: 0172
Product ID: 0172-5729_4f26d0af-7f08-49a1-8bba-46741aa83ad5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075511
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

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
A075511-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075511-002	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
A075511-001	AB
A075511-002	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 · 86 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	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075511-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075511-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A075511-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075511-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075511-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075511-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075511-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075511-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075511-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075511-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075511-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075511-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075511-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075511-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075511-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075511-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075511-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075511-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075511-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075511-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075511-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075511-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075511-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075511-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075511-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075511-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075511-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075511-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075511-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075511-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075511-002	AB	1	`74a2ff9319b5…`

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: 2027-12-31

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
4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	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
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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	Strength	SPL version
0172-5729-60	Famotidine	100 in 1 BOTTLE	TABLET, FILM COATED	100		20
0172-5729-70	Famotidine	500 in 1 BOTTLE	TABLET, FILM COATED	500		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0172-5729-00	EA - Each	0172-5729	e45c5118-c2f6-4bba-b35f-b7fe8145a04a	1	2012-07-24
0172-5729-10	EA - Each	0172-5729	e46d0ea3-60a7-4947-8009-8e79726f19df	1	2012-07-24
0172-5729-60	EA - Each	0172-5729	1c48807e-3ef8-4158-b21e-a5eaa7150d96	1	2012-07-24
0172-5729-70	EA - Each	0172-5729	1d99e451-87cf-467f-ac74-32f0399d7037	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	12
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FAMOTIDINE TABLET, FILM COATED [IVAX PHARMACEUTICALS, INC.]	11
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE TABLET [NORTHWIND PHARMACEUTICALS,LLC]	1
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE TABLET [NORTHWIND PHARMACEUTICALS,LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0172-5729	FAMOTIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	20	Current NDC, Legacy NDC, 2 package rows	20240601_4c6f4f9e-f3f5-4ecf-9f40-887e037e8847.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Proficient Rx LP	d60bde93-f512-4071-9e4b-1d8318def3bc	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	f2b6da72-72ea-d81b-e053-2995a90a9526	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	03503cd5-bd8e-4bff-b90d-1a71c5225b91	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	5798d282-ce83-49aa-bc33-13203f2b5285	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	A-S Medication Solutions	2bde8e1d-078f-4ba1-9ccb-29de6e36d8c4	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	A-S Medication Solutions	74ff64f2-d882-411f-bac8-29dfa4cb4f10	2023-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Proficient Rx LP	fe21daca-ac48-4b46-9cb3-9a69af0c6a84	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511
Famotidine	FAMOTIDINE	Teva Pharmaceuticals USA, Inc.	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	2019-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075511 application number: ANDA075511 ndc (product): 0172-5729

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	5798d282-ce83-49aa-bc33-13203f2b5285	22
284245	famotidine 40 MG Oral Tablet	SCD	5798d282-ce83-49aa-bc33-13203f2b5285	22
310273	famotidine 20 MG Oral Tablet	PSN	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	20
284245	famotidine 40 MG Oral Tablet	PSN	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	20
310273	famotidine 20 MG Oral Tablet	SCD	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	20
284245	famotidine 40 MG Oral Tablet	SCD	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	20
284245	famotidine 40 MG Oral Tablet	PSN	03503cd5-bd8e-4bff-b90d-1a71c5225b91	3
284245	famotidine 40 MG Oral Tablet	SCD	03503cd5-bd8e-4bff-b90d-1a71c5225b91	3
284245	famotidine 40 MG Oral Tablet	PSN	04281015-44ba-6197-e063-6394a90ab36a	1
284245	famotidine 40 MG Oral Tablet	PSN	fe21daca-ac48-4b46-9cb3-9a69af0c6a84	1
284245	famotidine 40 MG Oral Tablet	SCD	04281015-44ba-6197-e063-6394a90ab36a	1
284245	famotidine 40 MG Oral Tablet	SCD	fe21daca-ac48-4b46-9cb3-9a69af0c6a84	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0172-5729-60	00172572960	100 TABLET, FILM COATED in 1 BOTTLE (0172-5729-60)	2001-04-16	0000-00-00	No	No	Current
0172-5729-70	00172572970	500 TABLET, FILM COATED in 1 BOTTLE (0172-5729-70)	2001-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	3
Famotidine	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	22
Famotidine	NCS HealthCare of KY, LLC dba Vangard Labs	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	22
Famotidine	REMEDYREPACK INC.	2024-02-16	HUMAN PRESCRIPTION DRUG LABEL	9
Famotidine	NuCare Pharmaceuticals,Inc.	2023-08-30	HUMAN PRESCRIPTION DRUG LABEL	1
Famotidine	Proficient Rx LP	2023-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
Famotidine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Famotidine	Teva Pharmaceuticals USA, Inc.	2019-01-01	HUMAN PRESCRIPTION DRUG LABEL	21
FAMOTIDINE TABLETS USP Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2012-03-19	HUMAN PRESCRIPTION DRUG LABEL	2