Doxepin Hydrochloride
- Product NDC
- 80425-0316
- 11-digit product format
- 804250316
- Labeler code
- 80425
- Product ID
- 80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA213063
- Marketing category
- ANDA
- Marketing start
- 2023-04-10
- 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
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 |
|---|
| 80425-0316-1 | 80425031601 | 30 CAPSULE in 1 BOTTLE (80425-0316-1) | 30 capsule | 2023-04-10 | No | No | Historical |
| 80425-0316-2 | 80425031602 | 60 CAPSULE in 1 BOTTLE (80425-0316-2) | 60 capsule | 2023-04-10 | No | No | Historical |
| 80425-0316-3 | 80425031603 | 90 CAPSULE in 1 BOTTLE (80425-0316-3) | 90 capsule | 2023-04-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Doxepin HCL Capsule | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |