Doxepin
- Product NDC
- 10135-758
- 11-digit product format
- 101350758
- Labeler code
- 10135
- Product ID
- 10135-758_43029ddd-8941-add8-e063-6394a90a1e4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxepin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA202337
- Marketing category
- ANDA
- Marketing start
- 2023-10-01
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 3 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 | 3 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 |
|---|
| 10135-758-30 | Doxepin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-758 | DOXEPIN TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.] | 2 | Current NDC, 1 package rows | 20241004_06e79a65-1455-804e-e063-6394a90a2f3d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-758-30 | 10135075830 | 30 TABLET, FILM COATED in 1 BOTTLE (10135-758-30) | 2023-10-01 | No | No | Current |