TRAZODONE HYDROCHLORIDE

Product NDC: 61919-232
11-digit product format: 619190232
Labeler code: 61919
Product ID: 61919-232_9cad6942-f656-9038-e053-2a95a90a3a84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAZODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA071523
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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
61919-232-30	2023-01-30	C162847	48780-1	f386c64a-3dba-0266-e053-dadaa90a7c1a	TRAZODONE HYDROCHLORIDE
61919-232-60	2023-01-30	C162847	48780-1	f386c64a-3dba-0266-e053-dadaa90a7c1a	TRAZODONE HYDROCHLORIDE
61919-232-90	2023-01-30	C162847	48780-1	f386c64a-3dba-0266-e053-dadaa90a7c1a	TRAZODONE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-232-30	TRAZODONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		6
61919-232-60	TRAZODONE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60		6
61919-232-90	TRAZODONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-232-30	EA - Each	61919-232	16ffae29-a178-4cff-b0af-b166c617b378	1	2014-07-02
61919-232-60	EA - Each	61919-232	55281bd1-1180-4713-8808-0c987e829c53	1	2014-07-02
61919-232-90	EA - Each	61919-232	bb7f2f64-e738-4a0f-ad64-27cc22ce1b23	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-232	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	6	Legacy NDC, 3 package rows	20200131_1e3fdd78-63e8-44da-92d1-bf1c95cd12c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856373	traZODone HCl 100 MG Oral Tablet	PSN	1e3fdd78-63e8-44da-92d1-bf1c95cd12c2	6
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	1e3fdd78-63e8-44da-92d1-bf1c95cd12c2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-232-30	61919023230	30 TABLET in 1 BOTTLE (61919-232-30)	30 tablet	2014-01-01	0000-00-00	No	No	Current
61919-232-60	61919023260	60 TABLET in 1 BOTTLE (61919-232-60)	60 tablet	2014-01-01	0000-00-00	No	No	Current
61919-232-90	61919023290	90 TABLET in 1 BOTTLE (61919-232-90)	90 tablet	2014-01-01	0000-00-00	No	No	Current