Famotidine

Product NDC: 72189-543
Requested package NDC: 72189-543-30
11-digit product format: 721890543
Labeler code: 72189
Product ID: 72189-543_138d9ed1-2f90-d19d-e063-6394a90a695d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA075718
Marketing category: ANDA
Marketing start: 2024-03-13
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: 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
A075718-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075718-002	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
A075718-001	AB
A075718-002	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	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075718-002	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	A075718-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075718-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075718-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075718-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075718-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075718-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075718-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075718-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075718-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075718-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075718-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075718-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075718-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075718-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075718-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075718-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075718-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075718-002	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	20 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
138d9ed1-2f8f-d19d-e063-6394a90a695d	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	Strength	SPL version
72189-543-20	Famotidine	20 in 1 BOTTLE	TABLET, FILM COATED	20		1
72189-543-30	Famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-543-20	EA - Each	72189-543	70b1f25f-dd3b-49cb-b6e2-547681f471d5	1	2024-04-05
72189-543-30	EA - Each	72189-543	d08c5605-86e7-486c-ac92-9d3a092fa252	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-543	FAMOTIDINE TABLET, FILM COATED [DIRECT_RX]	1	Current NDC, 2 package rows	20240316_138d9ed1-2f8f-d19d-e063-6394a90a695d.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Major Pharmaceuticals	3e6d167f-91e4-4122-911d-d3da66386f44	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Sportpharm LLC	4421ceb7-a114-436c-871a-7bc5444f8154	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Proficient Rx LP	68d21d95-9603-4e68-855a-bfc65b1b58c3	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	5d515c2a-dac9-42d8-aede-66d28a427dbc	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	cdd5dfb7-4efb-4235-8023-5ce145c09038	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	545d5c1f-ec1c-4135-965f-333ad888d96f	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Legacy Pharmaceutical Packaging, LLC	cc88fbdc-546e-332f-e053-2995a90a8ca7	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	5ed77259-5dd9-4634-a073-346693488c4f	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	AvPAK	dfdca61d-8824-6230-e053-2995a90a209d	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Quality Care Products, LLC	3549386a-533d-4e44-8097-f6bc51ee494a	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Direct_Rx	138d9ed1-2f8f-d19d-e063-6394a90a695d	2024-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718 ndc (package): 72189-543-30 ndc (product): 72189-543 ndc11 (package): 72189054330
Famotidine	FAMOTIDINE	Dr.Reddy's Laboratories Limited	06d286ce-14b3-4b66-8b42-ac4a10a0fc90	2020-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718

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	138d9ed1-2f8f-d19d-e063-6394a90a695d	1
310273	famotidine 20 MG Oral Tablet	SCD	138d9ed1-2f8f-d19d-e063-6394a90a695d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-543-30	72189054330	30 TABLET, FILM COATED in 1 BOTTLE (72189-543-30)	2024-03-13	No	No	Current