Docetaxel
- Product NDC
- 47335-939
- 11-digit product format
- 473350939
- Labeler code
- 47335
- Product ID
- 47335-939_9a0d7b91-4324-4e19-9cd8-eb19266e771a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA022534
- Marketing category
- NDA
- Marketing start
- 2020-11-26
- Substance
- DOCETAXEL ANHYDROUS
- Active strength
- 160 mg/8mL
- 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
- Docetaxel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCETAXEL ANHYDROUS | 160 mg/8mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 699121PHCA |
| Rxcui | 1860480, 1860485, 1861411 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-939-40 | Docetaxel | 8 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 8 | | 6 |
| 47335-939-40 | Docetaxel | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-939 | DOCETAXEL INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20210205_c85b2c62-3c33-4cbc-8b79-d5e17851a1b4.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 |
|---|
| 47335-939-40 | 47335093940 | 1 VIAL, GLASS in 1 CARTON (47335-939-40) / 8 mL in 1 VIAL, GLASS | 2020-11-26 | 0000-00-00 | No | No | Current |