PENCICLOVIR
- Product NDC
- 45802-440
- 11-digit product format
- 458020440
- Labeler code
- 45802
- Product ID
- 45802-440_aa3c82bd-5e27-4b4d-af88-6b80e5779f2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- penciclovir
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA212368
- Marketing category
- ANDA
- Marketing start
- 2024-11-07
- 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
- PENCICLOVIR
- 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 | 312255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-440-75 | PENCICLOVIR | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 45802-440-75 | PENCICLOVIR | 5 g in 1 TUBE | CREAM | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-440 | PENCICLOVIR CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 2 | Current NDC, 2 package rows | 20241204_72da67d0-1349-4408-be13-9935bd9c0179.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 45802-440-75 | 45802044075 | 1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE | 1 tube | 2024-11-07 | No | No | Current |