TRAZODONE HYDROCHLORIDE

Product NDC: 13107-080
11-digit product format: 131070080
Labeler code: 13107
Product ID: 13107-080_db4e6aff-149f-4f16-9512-e81e0c3e6900
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAZODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Aurolife Pharma LLC
Application: ANDA204852
Marketing category: ANDA
Marketing start: 2015-09-15
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204852-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05
A204852-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05
A204852-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05
A204852-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204852-001	AB
A204852-002	AB
A204852-003	AB
A204852-004	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 4 · 152 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
2026-08-18 06:07:40	2026-07	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204852-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204852-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204852-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204852-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204852-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204852-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204852-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204852-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204852-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204852-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204852-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204852-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204852-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204852-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204852-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204852-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204852-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204852-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204852-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: TRAZODONE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAZODONE HYDROCHLORIDE	100 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
295e92a9-bcb0-4d53-ba62-e30020e9834b	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
13107-080-01	TRAZODONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	9
13107-080-05	TRAZODONE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	9
13107-080-30	TRAZODONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	9
13107-080-99	TRAZODONE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-080-01	EA - Each	13107-080	c01bd5bb-0e25-498f-81c8-83eab987c17c	1	2021-12-08
13107-080-05	EA - Each	13107-080	473060ab-1875-4e21-871b-d881014164a8	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-080	TRAZODONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC]	9	Current NDC, Legacy NDC, 4 package rows	20250412_295e92a9-bcb0-4d53-ba62-e30020e9834b.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	fec78f5d-2567-44d3-9f04-1a6913357019	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	34986e81-da05-46c1-8dd6-1dd7a8d1a44f	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	dfd2698d-b7a3-49e0-aa2f-1af0ca894b35	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f89ad429-0056-e4d6-e053-6294a90a7ab1	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	470a98a2-4e68-4c98-b3c8-e5eba4e55cdc	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	fdd35113-5f51-49c5-a29c-ffdddd28ef38	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	b57daea8-5a39-41c1-842e-b1d15115e36f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	24b5eee4-4210-4b90-a695-11e6a5868988	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	7baa8eef-3a5c-43b3-a5fe-0c449aacda2e	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	4370fe5c-1c40-499b-abb5-bca0a39834c6	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	a343910a-bf4c-4a41-b0ee-0e90e8355815	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	1514b3b0-7742-4247-b9fd-ea14849d3fdd	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	b0a79ee7-3140-48cb-b734-244a4420e32c	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Aurolife Pharma LLC	295e92a9-bcb0-4d53-ba62-e30020e9834b	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852 ndc (product): 13107-080
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30ca6faa-316d-5754-e063-6394a90a7eff	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8fc1f03-cd9d-9fa9-e053-6294a90a8665	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852

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	4370fe5c-1c40-499b-abb5-bca0a39834c6	100
856373	traZODone HCl 100 MG Oral Tablet	PSN	7baa8eef-3a5c-43b3-a5fe-0c449aacda2e	100
856373	traZODone HCl 100 MG Oral Tablet	PSN	b57daea8-5a39-41c1-842e-b1d15115e36f	100
856373	traZODone HCl 100 MG Oral Tablet	PSN	fdd35113-5f51-49c5-a29c-ffdddd28ef38	100
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	4370fe5c-1c40-499b-abb5-bca0a39834c6	100
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	7baa8eef-3a5c-43b3-a5fe-0c449aacda2e	100
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	b57daea8-5a39-41c1-842e-b1d15115e36f	100
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	fdd35113-5f51-49c5-a29c-ffdddd28ef38	100
856373	traZODone HCl 100 MG Oral Tablet	PSN	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856364	traZODone HCl 150 MG Oral Tablet	PSN	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856369	traZODone HCl 300 MG Oral Tablet	PSN	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856377	traZODone HCl 50 MG Oral Tablet	PSN	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856364	trazodone hydrochloride 150 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856369	trazodone hydrochloride 300 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	295e92a9-bcb0-4d53-ba62-e30020e9834b	9
856373	traZODone HCl 100 MG Oral Tablet	PSN	fec78f5d-2567-44d3-9f04-1a6913357019	7
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	fec78f5d-2567-44d3-9f04-1a6913357019	7
856373	traZODone HCl 100 MG Oral Tablet	PSN	f89ad429-0056-e4d6-e053-6294a90a7ab1	3
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	f89ad429-0056-e4d6-e053-6294a90a7ab1	3
856373	traZODone HCl 100 MG Oral Tablet	PSN	dfd2698d-b7a3-49e0-aa2f-1af0ca894b35	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	dfd2698d-b7a3-49e0-aa2f-1af0ca894b35	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-080-01	13107008001	100 TABLET in 1 BOTTLE (13107-080-01)	100 tablet	2015-09-15	0000-00-00	No	No	Current
13107-080-05	13107008005	500 TABLET in 1 BOTTLE (13107-080-05)	500 tablet	2015-09-15	0000-00-00	No	No	Current
13107-080-30	13107008030	30 TABLET in 1 BOTTLE (13107-080-30)	30 tablet	2015-09-15	0000-00-00	No	No	Current
13107-080-99	13107008099	1000 TABLET in 1 BOTTLE (13107-080-99)	1000 tablet	2015-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	7
TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	1
Trazodone HCL Tablet	Advanced Rx Pharmacy of Tennessee, LLC	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	3
TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	100
TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	100
TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	100
TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	100
TRAZODONE HYDROCHLORIDE	Aurolife Pharma LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-04-02	Human Prescription Drug Label	9