Trazodone Hydrochloride
- Product NDC
- 50090-4820
- Requested package NDC
- 50090-4820-0
- 11-digit product format
- 500904820
- Labeler code
- 50090
- Product ID
- 50090-4820_01b572f4-da8f-4372-8350-43078709d2c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA205253
- Marketing category
- ANDA
- Marketing start
- 2017-12-11
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 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 | 50090-4820 | 50090-4820-0 | I | Inactivated by FDA | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205253-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | |
| A205253-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | |
| A205253-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | |
| A205253-004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205253-001 | AB |
| A205253-002 | AB |
| A205253-003 | AB |
| A205253-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A205253-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2017-10-10 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A205253-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2017-10-10 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A205253-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2017-10-10 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A205253-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2017-10-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A205253-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A205253-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A205253-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A205253-004 | 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 | REMEDYREPACK INC. | 2863317d-657b-4dc6-81fb-b7158ea03498 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 007f38e0-653b-43e4-a1c1-b59997b2762a | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 68bcae4b-f4c3-4d28-af76-d182b707fc73 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | American Health Packaging | f715085a-be56-497e-ad92-9fec3aba70b5 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 614f2c6e-0bb7-43e0-85d8-5eef8eeae208 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 04c287ca-5efa-469d-ab39-ff16d9b1e0b3 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 6aaf08aa-9aa3-aabd-e053-2a91aa0a86d1 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 0545507a-5c11-4451-872a-d2f7f0aaecd4 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | a31d59ed-5949-4f85-8b73-3bfd7f72d5b8 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 51e1ef06-d2c8-46db-a2b4-f20d4cc1abf3 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 297cdf27-5b6e-4665-93f9-8fc6aef483a0 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Zydus Lifesciences Limited | 43d4be17-5fae-4326-a5c4-9e25e2db6a43 | 2026-01-23 | 205253 ANDA205253 | |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 4fcd25d5-e34f-4eea-aeff-aa442651e681 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | AvPAK | 9f1c2bf1-5204-7306-e053-2a95a90a9903 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 353e66cc-98ca-4500-97e7-00f23f122349 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b716575a-5b96-49c5-bcb2-56b05fbb7920 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | American Health Packaging | 094ca37b-3ae2-4889-9536-e7e5f20e3105 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | bb3ecde6-72ca-450c-ba88-9cf45c808d90 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 67d2a90a-3036-409c-aa32-937c55076547 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 205253 ANDA205253 |
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4820-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-dc3c-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4820-0 | Trazodone Hydrochloride | 33 in 1 CARTON | TABLET | 33 | 1 | |
| 50090-4820-0 | Trazodone Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4820 | TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20200107_55779b6d-c43e-4b62-8b03-ff037c9a4a20.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 55779b6d-c43e-4b62-8b03-ff037c9a4a20 | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 55779b6d-c43e-4b62-8b03-ff037c9a4a20 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4820-0 | 50090482000 | 33 BLISTER PACK in 1 CARTON (50090-4820-0) > 1 TABLET in 1 BLISTER PACK | 33 blister pack | 2019-12-31 | 0000-00-00 | No | No | Current |