Doxepin Hydrochloride
- Product NDC
- 70518-4231
- 11-digit product format
- 705184231
- Labeler code
- 70518
- Product ID
- 70518-4231_4005f90d-dae9-358c-e063-6394a90a6d07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA215113
- Marketing category
- ANDA
- Marketing start
- 2024-11-13
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000076 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4231-0 | Doxepin Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4231 | DOXEPIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20241116_670edc2b-7914-479e-b4dd-d5c86706a631.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 |
|---|
| 70518-4231-0 | 70518423100 | 30 CAPSULE in 1 BLISTER PACK (70518-4231-0) | 30 capsule | 2024-11-13 | No | No | Historical |