Zonalon
- Product NDC
- 0378-8123
- 11-digit product format
- 003788123
- Labeler code
- 0378
- Product ID
- 0378-8123_d08db934-a9ce-4b1a-9ca1-5c6705b227a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxepin hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020126
- Marketing category
- NDA
- Marketing start
- 2018-11-14
- 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
- Zonalon
- 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, 1000095 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8123 | ZONALON (DOXEPIN HYDROCHLORIDE) CREAM [MYLAN PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20181127_5f302247-525e-4acc-852b-00eb1d79af4b.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 |
|---|
| 0378-8123-30 | 00378812330 | 1 TUBE in 1 CARTON (0378-8123-30) / 30 g in 1 TUBE | 1 tube | 2018-11-26 | 0000-00-00 | No | No | Current |
| 0378-8123-45 | 00378812345 | 1 TUBE in 1 CARTON (0378-8123-45) / 45 g in 1 TUBE | 1 tube | 2018-11-14 | 0000-00-00 | No | No | Current |