Trazodone Hydrochloride

Product NDC: 42291-829
11-digit product format: 422910829
Labeler code: 42291
Product ID: 42291-829_4875c084-69f6-d254-e063-6294a90ada37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA071525
Marketing category: ANDA
Marketing start: 2020-04-17
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Trazodone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	150 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6E8ZO8LRNM
Rxcui	856364

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-829-50	Trazodone Hydrochloride	500 in 1 BOTTLE	TABLET	500		4
42291-829-90	Trazodone Hydrochloride	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-829-50	EA - Each	42291-829	fc8ca764-c07d-4f51-9ae0-1986ef4a4215	1	2020-05-08
42291-829-90	EA - Each	42291-829	351faaad-67c8-436d-ac51-f937054b8cf5	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-829	TRAZODONE HYDROCHLORIDE TABLET [AVKARE]	3	Current NDC, Legacy NDC, 2 package rows	20240111_a382ac4d-9ab9-796a-e053-2a95a90a2c26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856364	traZODone HCl 150 MG Oral Tablet	PSN	a382ac4d-9ab9-796a-e053-2a95a90a2c26	4
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	a382ac4d-9ab9-796a-e053-2a95a90a2c26	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-829-50	42291082950	500 TABLET in 1 BOTTLE (42291-829-50)	500 tablet	2020-04-17	0000-00-00	No	No	Current
42291-829-90	42291082990	90 TABLET in 1 BOTTLE (42291-829-90)	90 tablet	2020-04-17	0000-00-00	No	No	Current