Denavir
- Product NDC
- 0378-9720
- 11-digit product format
- 003789720
- Labeler code
- 0378
- Product ID
- 0378-9720_3f576b33-fe11-41ec-b6d2-6ed89b58fbcb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- penciclovir
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020629
- Marketing category
- NDA
- Marketing start
- 2018-09-24
- Substance
- PENCICLOVIR
- Active strength
- 10 mg/g
- Pharmacologic classes
- DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Denavir
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENCICLOVIR | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 359HUE8FJC |
| Rxcui | 211343, 312255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-9720-55 | Denavir | 5 g in 1 TUBE | CREAM | 5 | | 5 |
| 0378-9720-55 | Denavir | 1 in 1 CARTON | CREAM | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-9720 | DENAVIR (PENCICLOVIR) CREAM [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250130_61229829-55a0-4d6f-a423-4b48a2b4d8e5.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 |
|---|
| 0378-9720-55 | 00378972055 | 1 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBE | 1 tube | 2018-09-24 | 0000-00-00 | No | No | Current |