Doxepin Hydrochloride
- Product NDC
- 72789-542
- 11-digit product format
- 727890542
- Labeler code
- 72789
- Product ID
- 72789-542_463de429-bc73-951e-e063-6394a90add02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA211603
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- 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
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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000070 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-542-30 | Doxepin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 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 |
|---|
| 72789-542-30 | 72789054230 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-542-30) | 30 capsule | 2025-12-18 | No | No | Historical |