Prescription drug · ANDA
Paclitaxel Paclitaxel (Paclitaxel) NDC 23155-882
Paclitaxel 6 mg/mL · Injection, Solution · Intravenous · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-882-31 | 2315508823123155088231 | 1 VIAL, MULTI-DOSE in 1 CARTON (23155-882-31) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Aug 31, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 PaclitaxelSuffix: PACLITAXEL
- Generic name (nonproprietary)
- paclitaxel
- Active ingredients
- Paclitaxel — 6 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDC labeler code 23155
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207326
- Marketing start
- Listing expires
- Other FDA classes
- Microtubule Inhibition (Physiologic effect)
- Identifiers
- Product ID 23155-882_d4a15d93-5bab-4208-aa87-66131fd901cbSPL ID d4a15d93-5bab-4208-aa87-66131fd901cbSPL set ID b4c5d08a-e0f5-4af1-97d6-213705adedf1RxCUI 312199UNII P88XT4IS4DUPC 0323155883312, 0323155882315, 0323155884319
- 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
N423155088231followed by a unit qualifier and the quantityPackage 23155-0882-31. 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 is indicated in combination with cisplatin. Paclitaxel 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 the patients with estro…
Excerpt only. Read the full label for complete information.
About NDC 23155-882
- What is NDC 23155-882?
- 23155-882 is the product NDC for Paclitaxel Paclitaxel (paclitaxel), Paclitaxel 6 mg/mL injection, solution, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paclitaxel Paclitaxel (Paclitaxel).
- What is the active ingredient?
- Paclitaxel.
- Who is the labeler?
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. 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 Paclitaxel?
- 5 other product NDCs are listed under this name. See all Paclitaxel 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 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 Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-883 | 23155-0883-31 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-884 | 23155-0884-31 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-178 | 68083-0178-01 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-179 | 68083-0179-01 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-180 | 68083-0180-01 |
Other NDCs under ANDA 207326
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, SolutionIntravenous | Sagent Pharmaceuticals | 25021-255 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-883 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-884 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-178 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-179 |
| Paclitaxel Paclitaxelpaclitaxel | Paclitaxel 6 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-180 |