Doxepin
- Product NDC
- 70518-4327
- 11-digit product format
- 705184327
- Labeler code
- 70518
- Product ID
- 70518-4327_4265ca2a-3730-e458-e063-6294a90a1973
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxepin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202510
- Marketing category
- ANDA
- Marketing start
- 2025-04-13
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 6 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 |
|---|
| 70518-4327-0 | 70518432700 | 30 POUCH in 1 BOX (70518-4327-0) / 1 TABLET in 1 POUCH (70518-4327-1) | 30 pouch | 2025-04-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Doxepin | REMEDYREPACK INC. | 2025-04-12 | HUMAN PRESCRIPTION DRUG LABEL | 1 |