FAMOTIDINE

Product NDC: 80005-119
11-digit product format: 800050119
Labeler code: 80005
Product ID: 80005-119_7753e6db-5fe8-4b35-8817-c50abda35144
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FAMOTIDINE
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Carnegie Pharmaceuticals LLC
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
2026-02-19 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
2026-02-19 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: FAMOTIDINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	40 mg/5mL

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
310274	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
45df5fae-b28a-4b48-95ef-96e4faad883f	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
80005-119-16	FAMOTIDINE	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80005-119-16	ML - Milliliter	80005-119	b1beb061-b021-4626-a182-219e3319c3a6	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80005-119	FAMOTIDINE POWDER, FOR SUSPENSION [CARNEGIE PHARMACEUTICALS LLC]	6	Current NDC, 1 package rows	20230810_45df5fae-b28a-4b48-95ef-96e4faad883f.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 · 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 ndc (product): 80005-119
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310274	famotidine 40 MG in 5 mL Oral Suspension	PSN	900b4fd6-9c62-4b64-b4db-760c49ae0a42	100
310274	famotidine 8 MG/ML Oral Suspension	SCD	900b4fd6-9c62-4b64-b4db-760c49ae0a42	100
310274	famotidine 40 MG per 5 ML Oral Suspension	SY	900b4fd6-9c62-4b64-b4db-760c49ae0a42	100
310274	famotidine 40 MG in 5 mL Oral Suspension	PSN	45df5fae-b28a-4b48-95ef-96e4faad883f	7
310274	famotidine 8 MG/ML Oral Suspension	SCD	45df5fae-b28a-4b48-95ef-96e4faad883f	7
310274	famotidine 40 MG per 5 ML Oral Suspension	SY	45df5fae-b28a-4b48-95ef-96e4faad883f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80005-119-16	80005011916	50 mL in 1 BOTTLE (80005-119-16)	50 ml	2023-08-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FAMOTIDINE	Bryant Ranch Prepack	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	100
FAMOTIDINE	Carnegie Pharmaceuticals LLC	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	7