Trazodone Hydrochloride

Product NDC: 68071-4833
11-digit product format: 680714833
Labeler code: 68071
Product ID: 68071-4833_1ae16ffe-90f8-837f-e063-6394a90afbce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA205253
Marketing category: ANDA
Marketing start: 2017-12-11
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	100 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6E8ZO8LRNM
Rxcui	856373

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525e	Product name	1	20250730
b2f15d64-48ea-ba98-af5c-91f410667b31	Product name	5	20250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4833-1	2024-06-30	C162847	48780-1	ba0f9c33-43ad-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
68071-4833-1	2023-01-30	C162847	48780-1	ba0f9c33-43ad-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
68071-4833-1	2021-02-17	C162847	48780-1	ba0f9c33-43ad-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
68071-4833-1	2021-01-29	C162847	48780-1	ba0f9c33-43ad-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4833-1	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4833	TRAZODONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240701_85bb3f78-5cf2-1319-e053-2991aa0ade75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856373	traZODone HCl 100 MG Oral Tablet	PSN	85bb3f78-5cf2-1319-e053-2991aa0ade75	3
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	85bb3f78-5cf2-1319-e053-2991aa0ade75	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4833-1	68071483301	100 TABLET in 1 BOTTLE (68071-4833-1)	100 tablet	2019-04-04	0000-00-00	No	No	Current