Trazodone Hydrochloride
- Product NDC
- 53002-1132
- Requested package NDC
- 53002-1132-1
- 11-digit product format
- 530021132
- Labeler code
- 53002
- Product ID
- 53002-1132_994e9daa-4a90-4963-badc-c9d7c8de7b68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA071523
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53002-1132 | 53002-1132-1 | I | Inactivated by FDA | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071523-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071523-001 | 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | cb3db0bc1861… | |
| 2026-08-01 22:54:32 | 2026-06 | A071523-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 1987-12-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A071523-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071523-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A071523-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A071523-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A071523-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A071523-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A071523-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071523-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A071523-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A071523-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A071523-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A071523-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A071523-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A071523-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071523-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A071523-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A071523-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071523-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071523-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071523-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071523-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A071523-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A071523-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071523-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A071523-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A071523-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A071523-001 | AB | 1 | cb3db0bc1861… |
| 2026-08-01 22:54:32 | 2026-06 | A071523-001 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 562fdfb9-c060-63bc-e063-6294a90ad840 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 38e9820a-6edc-4bf5-b5e4-034b9e48b583 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 310c4b81-d2cf-4014-873d-e71d036105de | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | AvKARE | b3723265-7455-c25c-e053-2a95a90a379b | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Northwind Health Company, LLC | f2f2290f-b53c-3b38-e053-2995a90a157d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d42fd0c8-3673-4f18-a6c0-cd276bbf9fef | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5ab590d8-225f-43f4-bb68-1f2c86f9a886 | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 4006d439-e2de-4590-82e9-fc9d56e3ec1b | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | f6c3fb84-5b68-4675-a853-fe49bfbf3f9f | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 071523 ANDA071523 |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1132-0 | Trazodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 7 | |
| 53002-1132-1 | Trazodone Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 7 | |
| 53002-1132-3 | Trazodone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 7 | |
| 53002-1132-6 | Trazodone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1132 | TRAZODONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.] | 7 | Legacy NDC, 4 package rows | 20230609_8c859876-6b45-45b3-9eb2-5c7a5ea7a26f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-1132-1 | 53002113201 | 10 TABLET in 1 BOTTLE (53002-1132-1) | 10 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |