DOXEPIN HYDROCHLORIDE
- Product NDC
- 69315-163
- 11-digit product format
- 693150163
- Labeler code
- 69315
- Product ID
- 69315-163_ab05177e-b4a4-4cc5-b950-441858aaa0ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXEPIN HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA211618
- Marketing category
- ANDA
- Marketing start
- 2021-04-15
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 150 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000064 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-163-01 | DOXEPIN HYDROCHLORIDE | 100 in 1 PACKAGE | CAPSULE | 100 | | 6 |
| 69315-163-05 | DOXEPIN HYDROCHLORIDE | 500 in 1 PACKAGE | CAPSULE | 500 | | 6 |
| 69315-163-50 | DOXEPIN HYDROCHLORIDE | 50 in 1 PACKAGE | CAPSULE | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-163 | DOXEPIN HYDROCHLORIDE CAPSULE [LEADING PHARMA, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241009_d5df4beb-8048-4b83-aa59-19876437001d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69315-163-01 | 69315016301 | 100 CAPSULE in 1 PACKAGE (69315-163-01) | 100 capsule | 2021-04-15 | 0000-00-00 | No | No | Current |
| 69315-163-05 | 69315016305 | 500 CAPSULE in 1 PACKAGE (69315-163-05) | 500 capsule | 2021-04-15 | 0000-00-00 | No | No | Current |
| 69315-163-50 | 69315016350 | 50 CAPSULE in 1 PACKAGE (69315-163-50) | 50 capsule | 2021-04-15 | 0000-00-00 | No | No | Current |