doxepin hydrochloride
- Product NDC
- 51672-4246
- 11-digit product format
- 516724246
- Labeler code
- 51672
- Product ID
- 51672-4246_36adb81c-3442-17dc-e063-6394a90aaafa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxepin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA219058
- Marketing category
- ANDA
- Marketing start
- 2025-08-07
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 3 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 966787, 966793 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-4246-2 | doxepin hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51672-4246-2 | 51672424602 | 30 TABLET in 1 BOTTLE (51672-4246-2) | 30 tablet | 2025-08-07 | No | No | Current |