PRUDOXIN
- Product NDC
- 0378-8130
- 11-digit product format
- 003788130
- Labeler code
- 0378
- Product ID
- 0378-8130_dc5b7069-dc63-4393-bd87-2828328103b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxepin hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020126
- Marketing category
- NDA
- Marketing start
- 2018-08-01
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 50 mg/g
- 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
- PRUDOXIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXEPIN HYDROCHLORIDE | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 1000091, 1000093 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8130-45 | PRUDOXIN | 45 g in 1 TUBE | CREAM | 45 | | 2 |
| 0378-8130-45 | PRUDOXIN | 1 in 1 CARTON | CREAM | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8130 | PRUDOXIN (DOXEPIN HYDROCHLORIDE) CREAM [MYLAN PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20181121_ca53346b-8ab3-4722-98f6-cf272706d3fa.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 |
|---|
| 0378-8130-45 | 00378813045 | 1 TUBE in 1 CARTON (0378-8130-45) / 45 g in 1 TUBE | 1 tube | 2018-08-01 | 0000-00-00 | No | No | Current |