Trazodone Hydrochloride

Product NDC: 70010-234
Requested package NDC: 70010-234-03
11-digit product format: 700100234
Labeler code: 70010
Product ID: 70010-234_5096700d-3b93-70a3-e063-6294a90ad1d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA218988
Marketing category: ANDA
Marketing start: 2024-08-09
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218988-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08
A218988-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08
A218988-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08
A218988-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A218988-001	AB
A218988-002	AB
A218988-003	AB
A218988-004	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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218988-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218988-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218988-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218988-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-08-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218988-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218988-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218988-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218988-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218988-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218988-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218988-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218988-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218988-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218988-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218988-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218988-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218988-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218988-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218988-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218988-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218988-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218988-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218988-004	AB	1	`d06236e962d9…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218988 application number: ANDA218988 ndc (package): 70010-234-03 ndc (product): 70010-234 ndc11 (package): 70010023403
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	562fa890-0a39-9361-e063-6294a90a1bb5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218988 application number: ANDA218988
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	51012256-b249-ccbb-e063-6394a90af4fa	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218988 application number: ANDA218988
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	31356804-951b-68c7-e063-6294a90a6410	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218988 application number: ANDA218988
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	2c7dca0c-8313-7d85-e063-6294a90aca61	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218988 application number: ANDA218988

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	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6E8ZO8LRNM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856364	Internal RxNorm lookup
856369	Internal RxNorm lookup
856373	Internal RxNorm lookup
856377	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5bc5f266-6c0e-4b9a-b6e0-ea694928b948	Available on FDA.report

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	SPL version
70010-234-01	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100	4
70010-234-03	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30	4
70010-234-05	Trazodone Hydrochloride	500 in 1 BOTTLE	TABLET	500	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-234-01	EA - Each	70010-234	a11da341-2153-4e84-89d7-51f3c7598547	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-234	TRAZODONE HYDROCHLORIDE TABLET [GRANULES PHARMACEUTICALS INC.]	3	Current NDC, 3 package rows	20250326_5bc5f266-6c0e-4b9a-b6e0-ea694928b948.zip

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	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4
856364	traZODone HCl 150 MG Oral Tablet	PSN	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4
856369	traZODone HCl 300 MG Oral Tablet	PSN	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4
856377	traZODone HCl 50 MG Oral Tablet	PSN	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70010-234-03	70010023403	30 TABLET in 1 BOTTLE (70010-234-03)	30 tablet	2024-08-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	Granules Pharmaceuticals Inc. \| Granules India Limited	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	6