Trazodone Hydrochloride

Product NDC: 50111-441
11-digit product format: 501110441
Labeler code: 50111
Product ID: 50111-441_2f6356fb-56c5-4b3a-92ec-c881765bfc01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA071525
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 2021-10-31
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50111-441-01	EA - Each	50111-441	40fe84ed-e2e6-48e1-9039-fc77ad1fa22d	1	2012-07-24
50111-441-02	EA - Each	50111-441	03d7641f-25c2-44a3-a439-458471d6e8e8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]	2
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
Trazodone Hydrochloride	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Trazodone	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE	25332-39-2	TRAZODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856364	traZODone HCl 150 MG Oral Tablet	PSN	6963a2cc-1c0b-4795-acb4-024488d517ce	9
856377	traZODone HCl 50 MG Oral Tablet	PSN	6963a2cc-1c0b-4795-acb4-024488d517ce	9
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	6963a2cc-1c0b-4795-acb4-024488d517ce	9
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	6963a2cc-1c0b-4795-acb4-024488d517ce	9
856364	traZODone HCl 150 MG Oral Tablet	PSN	29c443fc-8ef6-4778-8d6a-ad14181ef8de	7
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	29c443fc-8ef6-4778-8d6a-ad14181ef8de	7
856364	traZODone HCl 150 MG Oral Tablet	PSN	e1ae415e-daf6-4b23-a545-e71a8acba1f6	3
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	e1ae415e-daf6-4b23-a545-e71a8acba1f6	3
856373	traZODone HCl 100 MG Oral Tablet	PSN	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856373	traZODone HCl 100 MG Oral Tablet	PSN	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856364	traZODone HCl 150 MG Oral Tablet	PSN	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856364	traZODone HCl 150 MG Oral Tablet	PSN	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856377	traZODone HCl 50 MG Oral Tablet	PSN	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856377	traZODone HCl 50 MG Oral Tablet	PSN	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856373	traZODone HCl 100 MG Oral Tablet	PSN	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856373	traZODone HCl 100 MG Oral Tablet	PSN	10124262-e443-49a5-a1cc-8cc34c74d953	1
856364	traZODone HCl 150 MG Oral Tablet	PSN	af82c9b0-1c3a-407a-aa5d-f15b9217b5c6	1
856364	traZODone HCl 150 MG Oral Tablet	PSN	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856364	traZODone HCl 150 MG Oral Tablet	PSN	10124262-e443-49a5-a1cc-8cc34c74d953	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	10124262-e443-49a5-a1cc-8cc34c74d953	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	10124262-e443-49a5-a1cc-8cc34c74d953	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	af82c9b0-1c3a-407a-aa5d-f15b9217b5c6	1
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	10124262-e443-49a5-a1cc-8cc34c74d953	1
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	10124262-e443-49a5-a1cc-8cc34c74d953	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50111-441-01	50111044101	100 TABLET in 1 BOTTLE (50111-441-01)	100 tablet	1990-09-30	2021-09-30	No	No	Current
50111-441-02	50111044102	500 TABLET in 1 BOTTLE (50111-441-02)	500 tablet	1990-09-30	2021-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	A-S Medication Solutions	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	7
TRAZODONE HYDROCHLORIDE	Direct Rx	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Carilion Materials Management	2014-06-11	HUMAN PRESCRIPTION DRUG LABEL	9
TRAZODONE HYDROCHLORIDE TABLETS, USP	Aidarex Pharmaceuticals LLC	2012-10-12	HUMAN PRESCRIPTION DRUG LABEL	1
TRAZODONE HYDROCHLORIDE TABLETS, USP	Physicians Total Care, Inc.	2012-03-04	HUMAN PRESCRIPTION DRUG LABEL	2
TRAZODONE HYDROCHLORIDE TABLETS, USP	Blenheim Pharmacal, Inc.	2011-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Trazodone Hydrochloride - STAT RX LLC USA	STAT RX LLC USA	2010-11-29	HUMAN PRESCRIPTION DRUG LABEL	1
TRAZODONE HYDROCHLORIDE TABLETS, USP	Rebel Distributors Corp.	2009-06-01	HUMAN PRESCRIPTION DRUG LABEL	2

Trazodone Hydrochloride

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#