Doxepin hydrochloride
- Product NDC
- 27241-168
- 11-digit product format
- 272410168
- Labeler code
- 27241
- Product ID
- 27241-168_4f6891be-49a9-4884-a1ce-35e148c7c156
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA212624
- Marketing category
- ANDA
- Marketing start
- 2019-12-20
- 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
- 2027-12-31
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 |
|---|
| 27241-168-01 | Doxepin hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 27241-168-10 | Doxepin hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27241-168 | DOXEPIN HYDROCHLORIDE CAPSULE [AJANTA PHARMA USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20211126_1513c98c-e7ef-4009-b932-6757048bb86a.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 |
|---|
| 27241-168-01 | 27241016801 | 100 CAPSULE in 1 BOTTLE (27241-168-01) | 100 capsule | 2019-12-20 | 0000-00-00 | No | No | Current |
| 27241-168-10 | 27241016810 | 1000 CAPSULE in 1 BOTTLE (27241-168-10) | 1000 capsule | 2020-02-20 | 0000-00-00 | No | No | Current |