Docetaxel
- Product NDC
- 43598-389
- 11-digit product format
- 435980389
- Labeler code
- 43598
- Product ID
- 43598-389_b06584c8-f4fd-46dd-a1f2-0e3672b24938
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA204193
- Marketing category
- ANDA
- Marketing start
- 2019-04-22
- Substance
- DOCETAXEL
- 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 |
|---|---|
| DOCETAXEL | 160 mg/8mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 15H5577CQD |
| Rxcui | 1860480, 1860485, 1861411 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| be52172d-e80b-4aac-aa81-254100bce67f | Product name | 9 | 20260304 |
| c4fcacbc-a699-410c-905b-642c4d134e72 | Product name | 1 | 20250616 |
| ad3381c5-7539-4a18-83b7-e7382b118d04 | Product name | 1 | 20231117 |
| 60a22813-7270-4733-af61-30636bce9f0f | Product name | 4 | 20180820 |
| 0179c4ba-fb03-4931-875d-b4f1ba528029 | Product name | 1 | 20160107 |
| 9ff92ef8-2da9-4645-bbf8-642e7eb0d754 | Product name | 1 | 20150812 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43598-389-57 | Docetaxel | 8 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 8 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43598-389-57 | ML - Milliliter | 43598-389 | 097239fa-5213-441c-9e36-b76fa2439237 | 1 | 2019-10-07 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| docetaxel | ACTIVE INGREDIENT | 15H5577CQD | DOCETAXEL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] | 7 | |
| DOCETAXEL ANHYDROUS | ACTIVE MOIETY | 699121PHCA | DOCETAXEL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] | 7 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DOCETAXEL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] | 7 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | DOCETAXEL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] | 7 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DOCETAXEL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1861411 | DOCEtaxel 160 MG in 8 ML Injection | PSN | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1860480 | DOCEtaxel 20 MG in 1 ML Injection | PSN | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1860485 | DOCEtaxel 80 MG in 4 ML Injection | PSN | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1860480 | 1 ML docetaxel 20 MG/ML Injection | SCD | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1860485 | 4 ML docetaxel 20 MG/ML Injection | SCD | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1861411 | 8 ML docetaxel 20 MG/ML Injection | SCD | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1861411 | docetaxel 160 MG per 8 ML Injection | SY | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1860480 | docetaxel 20 MG per 1 ML Injection | SY | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
| 1860485 | docetaxel 80 MG per 4 ML Injection | SY | a630937b-8369-74ad-b68a-f940eb16ff0f | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43598-389-57 | 43598038957 | 8 mL in 1 VIAL, GLASS (43598-389-57) | 8 ml | 2019-04-22 | 0000-00-00 | No | No | Current |