FAMOTIDINE

Product NDC: 81033-023
11-digit product format: 810330023
Labeler code: 81033
Product ID: 81033-023_446ca547-846c-dd5b-e063-6394a90a1bae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FAMOTIDINE
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Kesin Pharma Corporation
Application: ANDA217137
Marketing category: ANDA
Marketing start: 2023-08-10
Substance: FAMOTIDINE
Active strength: 40 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217137-001	FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB		2023-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217137-001	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.

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	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217137-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2023-07-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217137-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217137-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217137-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217137-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217137-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217137-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217137-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217137-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217137-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217137-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217137-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217137-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217137-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217137-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217137-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217137-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217137-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217137-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217137-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217137-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217137-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217137-001	AB	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217137-001	AB	1	`a50c72e98297…`

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/5mL

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	900b4fd6-9c62-4b64-b4db-760c49ae0a42	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217137 application number: ANDA217137
FAMOTIDINE	FAMOTIDINE	Carnegie Pharmaceuticals LLC	45df5fae-b28a-4b48-95ef-96e4faad883f	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217137 application number: ANDA217137
FAMOTIDINE	FAMOTIDINE	Biocon Pharma Inc.	ea7287a4-75e0-39d2-5b2e-b72b7cb386b9	2023-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217137 application number: ANDA217137

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	Units	Marketing start	Sample	Exclude flag	Status
81033-023-50	81033002350	50 mL in 1 BOTTLE (81033-023-50)	50 ml	2025-11-25	No	No	Current