Famotidine

Product NDC: 87441-030
11-digit product format: 874410030
Labeler code: 87441
Product ID: 87441-030_54d93c04-e982-c907-e063-6294a90aa703
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Solutions, Inc.
Application: ANDA206530
Marketing category: ANDA
Marketing start: 2026-06-22
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: 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
A206530-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22
A206530-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206530-001	AB
A206530-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB		2015-12-22	`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	A206530-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206530-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206530-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206530-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206530-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206530-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206530-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206530-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206530-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206530-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206530-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206530-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206530-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206530-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206530-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206530-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206530-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206530-002	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	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
54d93bf1-8f9a-981b-e063-6394a90a0fde	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Unit Dose Solutions, Inc.	54d93bf1-8f9a-981b-e063-6394a90a0fde	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530 ndc (product): 87441-030
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	11ce2a78-76ce-44df-afe3-57493498e596	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	Aurobindo Pharma Limited	b0798337-1a73-415e-8416-613984ce5c65	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	American Health Packaging	3a583080-6771-4246-a221-2491e9e5d8af	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	Proficient Rx LP	4adb4864-04ac-4cb1-96c2-6196a30ac640	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	A-S Medication Solutions	d8cfa644-7cad-41b9-82a0-242a783fcbc8	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	Proficient Rx LP	f32d0929-de22-4bec-9e24-bb549cf2679f	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	BluePoint Laboratories	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2021-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530

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
87441-030-01	87441003001	30 TABLET, FILM COATED in 1 BLISTER PACK (87441-030-01)	2026-06-22	No	No	Current