NDC 16729-231

Docetaxel

Docetaxel

Docetaxel is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Docetaxel Anhydrous.

• Product ID: 16729-231_6eb31fb5-dae4-45e1-e053-2a91aa0aa5d8
• NDC: 16729-231
• Product Type: Human Prescription Drug
• Proprietary Name: Docetaxel
• Generic Name: Docetaxel
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA201195
• Labeler Name: Accord Healthcare Inc.
• Substance Name: DOCETAXEL ANHYDROUS
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 16729-231-64

1 VIAL, SINGLE-DOSE in 1 CARTON (16729-231-64) > 4 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2012-07-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16729-231-63 [16729023163]

DOCETAXEL INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA201195
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-07-30
• Marketing End Date: 2019-06-21

NDC 16729-231-64 [16729023164]

DOCETAXEL INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA201195
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-07-30
• Marketing End Date: 2019-06-21

NDC 16729-231-65 [16729023165]

DOCETAXEL INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA201195
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-07-30
• Marketing End Date: 2019-06-21

Drug Details

Active Ingredients

Ingredient	Strength
DOCETAXEL ANHYDROUS	20 mg/mL

OpenFDA Data

• SPL SET ID: f59f7811-70b7-4c44-99f7-4f4fdce3ed22
• Manufacturer:
  • Accord Healthcare Inc.
• UNII:
  • 699121PHCA
• RxNorm Concept Unique ID - RxCUI:
  • 1001405
  • 1860485
  • 313949
  • 1860480
  • 1861411
• UPC Code:
  • 0316729120333
  • 0316729121316
  • 0316729121330

Pharmacological Class

• Microtubule Inhibition [PE]
• Microtubule Inhibitor [EPC]

NDC Crossover Matching brand name "Docetaxel" or generic name "Docetaxel"

NDC	Brand Name	Generic Name
0143-9204	Docetaxel	Docetaxel
0143-9205	Docetaxel	Docetaxel
0409-0016	Docetaxel	DOCETAXEL ANHYDROUS
0409-0201	Docetaxel	DOCETAXEL ANHYDROUS
0409-0365	Docetaxel	DOCETAXEL
0409-0366	Docetaxel	DOCETAXEL
0409-0367	Docetaxel	DOCETAXEL
0409-0368	Docetaxel	DOCETAXEL
0409-1732	Docetaxel	DOCETAXEL ANHYDROUS
0409-2026	Docetaxel	DOCETAXEL ANHYDROUS
0409-4235	Docetaxel	DOCETAXEL
70121-1222	Docetaxel	Docetaxel
70121-1223	Docetaxel	Docetaxel
70121-1221	Docetaxel	Docetaxel
0955-1022	Docetaxel	Docetaxel
0955-1020	Docetaxel	Docetaxel
0955-1021	Docetaxel	Docetaxel
16729-267	Docetaxel	Docetaxel
16729-231	Docetaxel	Docetaxel
25021-245	Docetaxel	Docetaxel
39822-2200	Docetaxel	Docetaxel
39822-2120	Docetaxel	Docetaxel
39822-2180	Docetaxel	Docetaxel
43066-001	Docetaxel	Docetaxel
43066-006	Docetaxel	Docetaxel
43066-010	Docetaxel	Docetaxel
43598-610	Docetaxel	Docetaxel
43598-258	Docetaxel	Docetaxel
43598-259	Docetaxel	Docetaxel
43598-611	Docetaxel	Docetaxel
45963-790	Docetaxel	Docetaxel
45963-734	Docetaxel	Docetaxel
45963-765	Docetaxel	Docetaxel
50742-428	DOCETAXEL	DOCETAXEL
50742-463	DOCETAXEL	DOCETAXEL
50742-431	DOCETAXEL	DOCETAXEL
57884-3043	Docetaxel	Docetaxel
57884-3021	Docetaxel	Docetaxel
57884-3042	Docetaxel	Docetaxel
57884-3041	Docetaxel	Docetaxel
63739-932	Docetaxel	Docetaxel
63739-971	Docetaxel	Docetaxel
66758-950	Docetaxel	Docetaxel
66758-050	Docetaxel	Docetaxel
67457-531	Docetaxel	Docetaxel
67457-533	Docetaxel	Docetaxel
67457-532	Docetaxel	Docetaxel
67457-781	Docetaxel	Docetaxel
0075-8003	TAXOTERE	Docetaxel
0075-8004	TAXOTERE	Docetaxel