Doxepin hydrochloride
- Product NDC
- 64980-595
- 11-digit product format
- 649800595
- Labeler code
- 64980
- Product ID
- 64980-595_2877d1f2-a036-4577-926d-b09828350ea1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA217975
- Marketing category
- ANDA
- Marketing start
- 2023-12-25
- 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 | 1000048, 1000058, 1000070, 1000076, 1000097 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64980-595-01 | Doxepin hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-595 | DOXEPIN HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 1 package rows | 20250502_66c6af99-9909-4b18-a43b-898a1c4a34d7.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 |
|---|
| 64980-595-01 | 64980059501 | 100 CAPSULE in 1 BOTTLE (64980-595-01) | 100 capsule | 2023-12-25 | No | No | Current |