Doxepin
- Product NDC
- 0228-3316
- 11-digit product format
- 002283316
- Labeler code
- 0228
- Product ID
- 0228-3316_84c77416-5f71-4fc9-b00b-964960f27241
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA201951
- Marketing category
- ANDA
- Marketing start
- 2020-01-02
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 6 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXEPIN HYDROCHLORIDE | 6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 966787, 966793 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-3316-03 | Doxepin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-3316 | DOXEPIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231108_c42333f8-1add-4f33-9458-6fe4436874a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0228-3316-03 | 00228331603 | 30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03) | 2020-01-02 | 0000-00-00 | No | No | Current |