Prescription drug · NDA
Ixempra (Ixabepilone) NDC 70020-1910
Kit · R-Pharm US Operating, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70020-1910-1 | 70020191001 | 1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USEMarketed from Oct 16, 2007 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Ixempra
- Generic name (nonproprietary)
- ixabepilone
- Dosage form
- Kit
- Labeler
- R-Pharm US Operating, LLCNDC labeler code 70020
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022065
- Marketing start
- Listing expires
- Identifiers
- Product ID 70020-1910_452ab301-102b-ac80-e063-6394a90ab113SPL ID 452ab301-102b-ac80-e063-6394a90ab113SPL set ID 241f0b1e-8b95-470d-876f-bf1804daaf18RxCUI 1726271, 1726274, 1726276, 1726278
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.
- NDC on a medical claim
N470020191001followed by a unit qualifier and the quantityPackage 70020-1910-01. 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)
IXEMPRA is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting [see Clinical Studies ( 14 )]. IXEMPRA is indicated as a single agent for the treatment of patients with metastatic…
Excerpt only. Read the full label for complete information.
About NDC 70020-1910
- What is NDC 70020-1910?
- 70020-1910 is the product NDC for Ixempra (ixabepilone) kit, listed with the FDA by R-Pharm US Operating, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ixempra (Ixabepilone).
- Who is the labeler?
- R-Pharm US Operating, LLC, NDC labeler code 70020. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ixempra?
- 1 other product NDC are listed under this name. See all Ixempra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ixempra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ixempraixabepilone | — | KitIntravenous | R-Pharm US Operating, LLC | 70020-1911 | 70020-1911-01 |
Other NDCs under NDA 022065
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 |
|---|---|---|---|---|
| Ixempraixabepilone | — | KitIntravenous | R-Pharm US Operating, LLC | 70020-1911 |