Trazodone Hydrochloride

Product NDC: 50111-434
11-digit product format: 501110434
Labeler code: 50111
Product ID: 50111-434_b39d3ec4-9b53-48a1-84c8-2b418c2d09f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA071524
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 2022-07-31
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 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
50111-434-01	EA - Each	50111-434	464771f4-4072-4191-889f-0ffcc2b1444e	1	2012-07-24
50111-434-02	EA - Each	50111-434	4d5c2ffc-489e-4840-af93-05e7c1467c1d	1	2012-07-24
50111-434-03	EA - Each	50111-434	dbd3de61-27a6-4e94-90f8-c9f20a132a71	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 HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	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
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	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
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]	2
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 (TRAZODONE HYDROCHORIDE) TABLET TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
Trazodone	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHORIDE) TABLET TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [STAT RX LLC USA]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHORIDE) TABLET TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHORIDE) TABLET TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	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 [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	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 (TRAZODONE HYDROCHORIDE) TABLET TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	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
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHORIDE) TABLET TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	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 (TRAZODONE HYDROCHORIDE) TABLET TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	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 [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
856373	traZODone HCl 100 MG Oral Tablet	PSN	d8096ecd-7c99-4db6-915d-2c5dd371a8a4	21
856377	traZODone HCl 50 MG Oral Tablet	PSN	d8096ecd-7c99-4db6-915d-2c5dd371a8a4	21
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	d8096ecd-7c99-4db6-915d-2c5dd371a8a4	21
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	d8096ecd-7c99-4db6-915d-2c5dd371a8a4	21
856373	traZODone HCl 100 MG Oral Tablet	PSN	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7
856377	traZODone HCl 50 MG Oral Tablet	PSN	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	8c859876-6b45-45b3-9eb2-5c7a5ea7a26f	7
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
856373	traZODone HCl 100 MG Oral Tablet	PSN	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856373	traZODone HCl 100 MG Oral Tablet	PSN	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856373	traZODone HCl 100 MG Oral Tablet	PSN	2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec	2
856364	traZODone HCl 150 MG Oral Tablet	PSN	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856364	traZODone HCl 150 MG Oral Tablet	PSN	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	2
856377	traZODone HCl 50 MG Oral Tablet	PSN	df555ed8-2d8c-45fd-8bf1-aa72c49090c0	2
856377	traZODone HCl 50 MG Oral Tablet	PSN	6f43cdc2-4f8e-4a5f-976a-d3aaac65593d	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
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec	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	eceb9837-9cf1-4b48-aad7-ed3c905d3a08	1
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
856373	traZODone HCl 100 MG Oral Tablet	PSN	28080f0c-0b6c-4d95-8a53-6474bb876b0e	1
856373	traZODone HCl 100 MG Oral Tablet	PSN	29e4012e-05bb-4aff-9f20-f0c17a06a29e	1
856364	traZODone HCl 150 MG Oral Tablet	PSN	10124262-e443-49a5-a1cc-8cc34c74d953	1
856364	traZODone HCl 150 MG Oral Tablet	PSN	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	10124262-e443-49a5-a1cc-8cc34c74d953	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	28080f0c-0b6c-4d95-8a53-6474bb876b0e	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	29e4012e-05bb-4aff-9f20-f0c17a06a29e	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	3f8d7e17-b580-4340-bd8f-e76f8ba00422	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	28080f0c-0b6c-4d95-8a53-6474bb876b0e	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	10124262-e443-49a5-a1cc-8cc34c74d953	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	eceb9837-9cf1-4b48-aad7-ed3c905d3a08	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	28080f0c-0b6c-4d95-8a53-6474bb876b0e	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
50111-434-01	50111043401	100 TABLET in 1 BOTTLE (50111-434-01)	100 tablet	1990-09-30	2022-07-31	No	No	Current
50111-434-02	50111043402	500 TABLET in 1 BOTTLE (50111-434-02)	500 tablet	1990-09-30	2022-07-31	No	No	Current
50111-434-03	50111043403	1000 TABLET in 1 BOTTLE (50111-434-03)	1000 tablet	1990-09-30	2022-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	7
Trazodone Hydrochloride	A-S Medication Solutions	2021-06-18	HUMAN PRESCRIPTION DRUG LABEL	21
TRAZODONE HYDROCHLORIDE	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	6
Trazodone Hydrochloride	Aidarex Pharmaceuticals LLC	2016-12-06	HUMAN PRESCRIPTION DRUG LABEL	1
Trazodone Hydrochloride	Blenheim Pharmacal, Inc.	2015-12-29	HUMAN PRESCRIPTION DRUG LABEL	1
Trazodone Hydrochloride	TYA Pharmaceuticals	2014-06-11	HUMAN PRESCRIPTION DRUG LABEL	2
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 - STAT RX LLC USA	STAT RX LLC USA	2010-11-29	HUMAN PRESCRIPTION DRUG LABEL	1
TRAZODONE HYDROCHLORIDE TABLETS, USP	Contract Pharmacy Services-PA	2010-03-09	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#