Trazodone Hydrochloride

Product NDC: 70010-231
Requested package NDC: 70010-231-10
11-digit product format: 700100231
Labeler code: 70010
Product ID: 70010-231_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: 50 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…`

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	50 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
70010-231-01	Trazodone Hydrochloride	100 in 1 BOTTLE	TABLET	100	4
70010-231-03	Trazodone Hydrochloride	30 in 1 BOTTLE	TABLET	30	4
70010-231-05	Trazodone Hydrochloride	500 in 1 BOTTLE	TABLET	500	4
70010-231-10	Trazodone Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-231-01	EA - Each	70010-231	1b6e1422-cde2-4bc9-a20f-e0d6266e4008	1	2024-09-09
70010-231-05	EA - Each	70010-231	028c9590-9774-49eb-a441-8d5c29304fb8	1	2024-09-09
70010-231-10	EA - Each	70010-231	a228ec12-f4aa-4870-8d02-09bbc90dce3d	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-231	TRAZODONE HYDROCHLORIDE TABLET [GRANULES PHARMACEUTICALS INC.]	3	Current NDC, 4 package rows	20250326_5bc5f266-6c0e-4b9a-b6e0-ea694928b948.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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): 70010-231-10 ndc (product): 70010-231 ndc11 (package): 70010023110
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

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
856377	traZODone HCl 50 MG Oral Tablet	PSN	2c7dca0c-8313-7d85-e063-6294a90aca61	2
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	2c7dca0c-8313-7d85-e063-6294a90aca61	2
856373	traZODone HCl 100 MG Oral Tablet	PSN	51012256-b249-ccbb-e063-6394a90af4fa	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	51012256-b249-ccbb-e063-6394a90af4fa	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	51012256-b249-ccbb-e063-6394a90af4fa	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	51012256-b249-ccbb-e063-6394a90af4fa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70010-231-10	70010023110	1000 TABLET in 1 BOTTLE (70010-231-10)	1000 tablet	2024-10-01	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
Trazodone Hydrochloride	Golden State Medical Supply, Inc.	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	1
Trazodone Hydrochloride	Coupler LLC	2025-01-27	HUMAN PRESCRIPTION DRUG LABEL	2