Prescription drug · ANDA
Paclitaxel NDC 0703-3213
Paclitaxel 6 mg/mL · Injection, Solution, Concentrate · Intravenous · Teva Parenteral Medicines, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0703-3213-01 | 00703321301 | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-01) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 7, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Paclitaxel
- Generic name (nonproprietary)
- paclitaxel
- Active ingredients
- Paclitaxel — 6 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Teva Parenteral Medicines, Inc.NDC labeler code 0703
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075184
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 0703-3213_26567d69-d05c-44e5-b3ca-e4504aa3c8a6SPL ID 26567d69-d05c-44e5-b3ca-e4504aa3c8a6SPL set ID e4be6cbf-72b9-4f7f-9b1b-459b2d35961aRxCUI 312199UNII P88XT4IS4DUPC 0307033213019
- Pharmacologic class
- Microtubule Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400703321301followed by a unit qualifier and the quantityPackage 00703-3213-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in …
Excerpt only. Read the full label for complete information.
About NDC 0703-3213
- What is NDC 0703-3213?
- 0703-3213 is the product NDC for Paclitaxel, Paclitaxel 6 mg/mL injection, solution, concentrate, listed with the FDA by Teva Parenteral Medicines, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paclitaxel.
- What is the active ingredient?
- Paclitaxel.
- Who is the labeler?
- Teva Parenteral Medicines, Inc., NDC labeler code 0703. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Paclitaxel?
- 30 other product NDCs are listed under this name. See all Paclitaxel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paclitaxel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paclitaxel | Paclitaxel 6 mg/mL | InjectionIntravenous | BluePoint Laboratories | 68001-705 | 68001-0705-27 |
| Paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Mylan Institutional LLC | 67457-937 | 67457-0937-50 |
| Paclitaxelpaclitaxel (aibumin-bound) | Paclitaxel 100 mg/100mg | Injection, Powder, Lyophilized, For suspensionIntravenous | Ningbo Shuangcheng Pharmaceutical Co., Ltd | 75007-041 | — |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 61703-015 | 61703-0015-04 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-229 | 69339-0229-50 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-227 | 69339-0227-05 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-228 | 69339-0228-17 |
| Paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Sandoz Inc | 0781-3531 | 00781-3531-91 |
| Paclitaxel | Paclitaxel 100 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Teva Pharmaceuticals, Inc. | 0480-3290 | 00480-3290-01 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-255 | 25021-0255-0525021-0255-1725021-0255-50 |
Other NDCs under ANDA 075184
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, Solution, ConcentrateIntravenous | Teva Parenteral Medicines, Inc. | 0703-3218 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, Solution, ConcentrateIntravenous | Teva Parenteral Medicines, Inc. | 0703-3218 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, Solution, ConcentrateIntravenous | Teva Parenteral Medicines, Inc. | 0703-3216 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, Solution, ConcentrateIntravenous | Teva Parenteral Medicines, Inc. | 0703-3216 |
| Paclitaxel | Paclitaxel 6 mg/mL | Injection, Solution, ConcentrateIntravenous | Teva Parenteral Medicines, Inc. | 0703-3217 |