PACLITAXEL
- Product NDC
- 68083-179
- 11-digit product format
- 680830179
- Labeler code
- 68083
- Product ID
- 68083-179_aeff20f1-c4e7-46c6-a6cb-f0aab334571b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paclitaxel
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA207326
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- Substance
- PACLITAXEL
- Active strength
- 6 mg/mL
- Pharmacologic classes
- Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PACLITAXEL
- Brand name suffix
- PACLITAXEL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PACLITAXEL | 6 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P88XT4IS4D |
| Rxcui | 312199 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-179-01 | PACLITAXELPACLITAXEL | 16.7 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 16.7 | | 3 |
| 68083-179-01 | PACLITAXELPACLITAXEL | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-179 | PACLITAXEL PACLITAXEL (PACLITAXEL) INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20160930_fec9ddee-53a9-4a61-ad0a-be6b604de084.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 |
|---|
| 68083-179-01 | 68083017901 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-179-01) / 16.7 mL in 1 VIAL, MULTI-DOSE | 2016-09-30 | 0000-00-00 | No | No | Current |