FAMOTIDINE

Product NDC: 68382-444
11-digit product format: 683820444
Labeler code: 68382
Product ID: 68382-444_707e6805-7f07-43d1-b65b-4afbb9e9e95e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: famotidine
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA091020
Marketing category: ANDA
Marketing start: 2021-04-22
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68382-444-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68382-444-05	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68382-444-05	`110d247fa046…`	`a55b01930146…`

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
A091020-001	FAMOTIDINE	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB		2010-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091020-001	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.

Product history page 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091020-001	FAMOTIDINE	40MG/5ML	FOR SUSPENSION / ORAL	AB	2010-05-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091020-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091020-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091020-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091020-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091020-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091020-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091020-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091020-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091020-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091020-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091020-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091020-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091020-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091020-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091020-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091020-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091020-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091020-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091020-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091020-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091020-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091020-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091020-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091020-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091020-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091020-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091020-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091020-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091020-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091020-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091020-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091020-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091020-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091020-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091020-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091020-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091020-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091020-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091020-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091020-001	AB	1	`cb3db0bc1861…`

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
a8010e10-68fd-455f-968f-d62a1c3e0ffd	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
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68382-444-05	2021-04-22	C162847	48780-1	956f9ecf-db84-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use FAMOTIDINE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for FAMOTIDINE FOR ORAL SUSPENSION. Famotidine for oral suspension Initial U.S. Approval:1986
68382-444-05	2019-10-21	C162847	48780-1	956f9ecf-db84-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use FAMOTIDINE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for FAMOTIDINE FOR ORAL SUSPENSION. Famotidine for oral suspension Initial U.S. Approval:1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-444-05	FAMOTIDINE	50 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SUSPENSION	50		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-444-05	ML - Milliliter	68382-444	37a88c04-dfac-474f-aeb6-e3a9938b39d4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
METHYLPARABEN SODIUM	INACTIVE INGREDIENT	CR6K9C2NHK	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-444	FAMOTIDINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC.]	3	Current NDC, Legacy NDC, 1 package rows	20221213_a8010e10-68fd-455f-968f-d62a1c3e0ffd.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	Zydus Pharmaceuticals USA Inc.	a8010e10-68fd-455f-968f-d62a1c3e0ffd	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091020 application number: ANDA091020 ndc (product): 68382-444
famotidine	FAMOTIDINE	Navinta LLC	0f34a3be-7554-4040-b808-5ba8bf064abc	2022-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091020 application number: ANDA091020

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	a8010e10-68fd-455f-968f-d62a1c3e0ffd	3
310274	famotidine 8 MG/ML Oral Suspension	SCD	a8010e10-68fd-455f-968f-d62a1c3e0ffd	3
310274	famotidine 40 MG per 5 ML Oral Suspension	SY	a8010e10-68fd-455f-968f-d62a1c3e0ffd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-444-05	68382044405	50 mL in 1 BOTTLE, PLASTIC (68382-444-05)	50 ml	2021-04-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FAMOTIDINE	Zydus Pharmaceuticals USA Inc. \| Navinta LLC \| Apothecon Pharmaceuticals Pvt Ltd	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	3