Famotidine

Product NDC: 85766-222
Requested package NDC: 85766-222-14
11-digit product format: 857660222
Labeler code: 85766
Product ID: 85766-222_5522df17-39cd-040b-e063-6394a90a5ae9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA075718
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: 2027-12-31
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: 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
4421ceb7-a114-436c-871a-7bc5444f8154	Available on FDA.report

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 ndc (package): 85766-222-14 ndc (product): 85766-222 ndc11 (package): 85766022214
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-222-14	85766022214	14 TABLET, FILM COATED in 1 BOTTLE (85766-222-14)	2026-06-26	No	No	Current