Doxepin Hydrochloride
- Product NDC
- 54838-512
- 11-digit product format
- 548380512
- Labeler code
- 54838
- Product ID
- 54838-512_5408fdf5-16a7-4d5a-b4c4-2ccb271759a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA074721
- Marketing category
- ANDA
- Marketing start
- 1998-12-29
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000054 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54838-512-40 | Doxepin Hydrochloride | 120 mL in 1 BOTTLE, PLASTIC | SOLUTION | 120 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54838-512 | DOXEPIN HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] | 22 | Current NDC, Legacy NDC, 1 package rows | 20230411_f350afed-120b-422d-9e6e-3aaa0f72a5fb.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 |
|---|
| 54838-512-40 | 54838051240 | 120 mL in 1 BOTTLE, PLASTIC (54838-512-40) | 120 ml | 1998-12-29 | 0000-00-00 | No | No | Current |