DOXEPIN HYDROCHLORIDE
- Product NDC
- 71335-2557
- 11-digit product format
- 713352557
- Labeler code
- 71335
- Product ID
- 71335-2557_7ddbac07-caff-42db-8b93-d9ac99bb4f3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXEPIN HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215076
- Marketing category
- ANDA
- Marketing start
- 2021-04-23
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2557_7ddbac07-caff-42db-8b93-d9ac99bb4f3e
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- DOXEPIN HYDROCHLORIDE
- Generic name
- DOXEPIN HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2021-04-23
- Marketing category
- ANDA
- Application number
- ANDA215076
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| DOXEPIN HYDROCHLORIDE | 25 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000070 |
| Spl Set Id | 06e027bb-516d-4a1d-b5a0-a66c051eb367 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3U9A0FE9N5 | DOXEPIN HYDROCHLORIDE | 1229-29-4 | DOXEPIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2557-1 | 71335255701 | 30 CAPSULE in 1 BOTTLE (71335-2557-1) | 30 capsule | 2025-01-23 | No | No | Current |
| 71335-2557-2 | 71335255702 | 60 CAPSULE in 1 BOTTLE (71335-2557-2) | 60 capsule | 2025-01-23 | No | No | Current |
| 71335-2557-3 | 71335255703 | 28 CAPSULE in 1 BOTTLE (71335-2557-3) | 28 capsule | 2025-01-23 | No | No | Current |
| 71335-2557-4 | 71335255704 | 18 CAPSULE in 1 BOTTLE (71335-2557-4) | 18 capsule | 2025-01-23 | No | No | Current |
| 71335-2557-5 | 71335255705 | 90 CAPSULE in 1 BOTTLE (71335-2557-5) | 90 capsule | 2025-01-23 | No | No | Current |