Trazodone Hydrochloride

Product NDC: 0603-6160
Requested package NDC: 0603-6160-21
11-digit product format: 006036160
Labeler code: 0603
Product ID: 0603-6160_33d705b2-795f-4fb8-96f2-96d48e6de326
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA072192
Marketing category: ANDA
Marketing start: 2010-05-30
Marketing end: 2021-06-30
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 50 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0603-6160	0603-6160-21	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072192-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1989-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A072192-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A072192-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1989-02-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A072192-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	283c8236-9776-44cb-b7b2-1024689de736	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072192 application number: ANDA072192

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
0603-6160-02	EA - Each	0603-6160	53291d95-1ad7-46ef-92d1-654f359e3020	1	2012-07-24
0603-6160-13	EA - Each	0603-6160	47032b78-bbe5-491e-95ce-c4abcb857be9	1	2012-07-24
0603-6160-16	EA - Each	0603-6160	ca1c2735-7276-40c8-83a0-2e8348f63c95	1	2012-07-24
0603-6160-20	EA - Each	0603-6160	47e15cc7-5163-47d2-bb76-f5d759e5c3a1	1	2012-07-24
0603-6160-21	EA - Each	0603-6160	72c19f02-8b19-4a0e-8c09-214380228868	1	2012-07-24
0603-6160-28	EA - Each	0603-6160	ace52fab-1d3e-40d2-b54c-ed5ac1deaa82	1	2012-07-24
0603-6160-32	EA - Each	0603-6160	8a89ecc3-101f-4810-987c-36fc03c3c802	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, FILM COATED [QUALITEST PHARMACEUTICALS]	14
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Trazodone Hydrochloride	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
trazodone	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	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	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856377	traZODone HCl 50 MG Oral Tablet	PSN	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	66da652a-72b4-c17f-e053-2a91aa0a8d69	3
856377	traZODone HCl 50 MG Oral Tablet	PSN	7202fa6e-86ed-813b-e053-2a95a90a7055	2
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	7202fa6e-86ed-813b-e053-2a95a90a7055	2
856373	traZODone HCl 100 MG Oral Tablet	PSN	26d30297-fda9-45a4-b94a-a9f401705818	1
856373	traZODone HCl 100 MG Oral Tablet	PSN	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	26d30297-fda9-45a4-b94a-a9f401705818	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	467cacc2-646f-342c-e054-00144ff8d46c	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	26d30297-fda9-45a4-b94a-a9f401705818	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	26d30297-fda9-45a4-b94a-a9f401705818	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	467cacc2-646f-342c-e054-00144ff8d46c	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-6160-21	00603616021	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6160-21)	2010-05-30	2021-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Medsource Pharmaceuticals \| Medsource Pharamceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
Trazodone Hydrochloride	Par Pharmaceutical	2019-11-12	HUMAN PRESCRIPTION DRUG LABEL	19
Trazodone Hydrochloride	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	2
TRAZODONE HYDROCHLORIDE	DIRECT RX	2019-04-25	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Apotheca Inc.	2017-01-19	HUMAN PRESCRIPTION DRUG LABEL	1
Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2014-05-13	HUMAN PRESCRIPTION DRUG LABEL	1
TRAZODONE HYDROCHLORIDE TABLETS, USP	Contract Pharmacy Services-PA	2010-08-11	HUMAN PRESCRIPTION DRUG LABEL	1