Trazodone Hydrochloride
- Product NDC
- 70934-818
- 11-digit product format
- 709340818
- Labeler code
- 70934
- Product ID
- 70934-818_ba49752a-083c-e13f-e053-2995a90adf78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA205253
- Marketing category
- ANDA
- Marketing start
- 2021-01-29
- 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
- 2022-12-31
- 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 product | product | 70934-818 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70934-818 | 70934-818-30 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70934-818 | 70934-818-90 | D | Discontinued by firm | 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70934-818-30 | EA - Each | 70934-818 | bf0e21dd-b6c6-4b92-954b-b40d958cac3f | 1 | 2023-01-09 |
| 70934-818-90 | EA - Each | 70934-818 | 11b25452-0127-4a62-addf-602b7e01ec59 | 1 | 2023-01-09 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-818-30 | 70934081830 | 30 TABLET in 1 BOTTLE, PLASTIC (70934-818-30) | 30 tablet | 2021-02-01 | 0000-00-00 | No | No | Current |
| 70934-818-90 | 70934081890 | 90 TABLET in 1 BOTTLE, PLASTIC (70934-818-90) | 90 tablet | 2021-01-29 | 0000-00-00 | No | No | Current |