Vinorelbine
- Product NDC
- 45963-607
- 11-digit product format
- 459630607
- Labeler code
- 45963
- Product ID
- 45963-607_1a467892-817b-4ff8-a58e-b69e0c3462cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vinorelbine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078011
- Marketing category
- ANDA
- Marketing start
- 2015-03-01
- Substance
- VINORELBINE TARTRATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Vinca Alkaloid [EPC], Vinca Alkaloids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vinorelbine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VINORELBINE TARTRATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 253GQW851Q |
| Rxcui | 1729418, 1729422 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45963-607-55 | Vinorelbine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 31 |
| 45963-607-55 | Vinorelbine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 31 |
| 45963-607-56 | Vinorelbine | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 31 |
| 45963-607-56 | Vinorelbine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 31 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-607 | VINORELBINE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 31 | Current NDC, Legacy NDC, 4 package rows | 20230613_dd3dcc9a-e40c-4677-9ee6-f318e7c7d835.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-607-55 | 45963060755 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE | 2015-03-01 | 0000-00-00 | No | No | Current |
| 45963-607-56 | 45963060756 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE | 2015-03-01 | 0000-00-00 | No | No | Current |