Doxepin hydrochloride
- Product NDC
- 70518-4297
- 11-digit product format
- 705184297
- Labeler code
- 70518
- Product ID
- 70518-4297_401df14b-32cf-1c71-e063-6394a90a6ad4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214823
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Doxepin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXEPIN HYDROCHLORIDE | 6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 966793 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4297-0 | Doxepin hydrochloride | 30 in 1 BOX | TABLET | 30 | | 2 |
| 70518-4297-1 | Doxepin hydrochloride | 1 in 1 POUCH | TABLET | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4297 | DOXEPIN HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20250302_7a8c56ab-5dd1-4e1a-b26a-3af45b961dd0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4297-0 | 70518429700 | 30 POUCH in 1 BOX (70518-4297-0) / 1 TABLET in 1 POUCH (70518-4297-1) | 30 pouch | 2025-02-27 | No | No | Historical |
| 70518-4297-1 | 70518429701 | 1 in 1 POUCH | | | | | Historical |