Trazodone Hydrochloride
- Product NDC
- 55700-957
- Requested package NDC
- 55700-957-60
- 11-digit product format
- 557000957
- Labeler code
- 55700
- Product ID
- 55700-957_7b63321a-c3cb-4b5d-af98-3043c12f4433
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA202180
- Marketing category
- ANDA
- Marketing start
- 2022-01-21
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 55700-957 | 55700-957-60 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202180-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | |
| A202180-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | |
| A202180-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | |
| A202180-004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202180-001 | AB |
| A202180-002 | AB |
| A202180-003 | AB |
| A202180-004 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2013-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2013-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2013-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2013-11-27 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202180-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202180-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202180-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202180-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202180-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202180-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202180-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202180-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202180-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202180-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202180-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202180-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202180-004 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 1f74b23d-f2eb-4c18-a583-d608b7713694 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | acd077db-e2b8-4d29-94c0-128439050c66 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | 1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f98b1e8f-9c66-3e9c-e053-6294a90ab057 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | f7e6a78e-7ac3-35b9-e053-6294a90aabd0 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | adc7427e-3553-4805-b063-eeda84049029 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fc9b90d1-7da5-efc1-e053-6294a90a0223 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 29ac7183-e574-506e-e063-6394a90a77c9 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | be0dc037-d30a-4f07-ab7c-1695637b3740 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | a71063f9-cdc6-46bc-9eb4-626f288e46d9 | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone HCL | TRAZODONE HCL | Direct_Rx | 1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c | 2024-08-16 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Medsource Pharmaceuticals | 138fef7b-db83-88c4-e063-6394a90ab0ac | 2024-03-13 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | 3c8c3d2b-9108-40fa-90d9-6ed545cf6549 | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | 2a1d0989-6ed5-4a2f-bd03-73d61eb40232 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 202180 ANDA202180 |
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-957-30 | EA - Each | 55700-957 | ed86824e-ee9f-43ec-a082-0e794b25dfea | 1 | 2022-03-09 |
| 55700-957-60 | EA - Each | 55700-957 | c9e08051-19ce-4104-8114-f9479f100f75 | 1 | 2022-09-12 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-957-60 | 55700095760 | 60 TABLET in 1 BOTTLE (55700-957-60) | 60 tablet | 2022-05-26 | 0000-00-00 | No | No | Current |