Prescription drug · ANDA
Bleomycin (bleomycin sulfate) NDC 71288-106
Bleomycin sulfate 15 [USP'U]/1 · Powder, For solution · Intramuscular, Intrapleural, Intravenous, Subcutaneous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-106-10 | 71288010610 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-106-10) / 15 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Aug 31, 2018 |
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)
- Bleomycin
- Generic name (nonproprietary)
- bleomycin sulfate
- Active ingredients
- Bleomycin sulfate — 15 [USP'U]/1
- Dosage form
- Powder, For solution
- Route
- Intramuscular, Intrapleural, Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205030
- Marketing start
- Listing expires
- Identifiers
- Product ID 71288-106_322a4cec-4797-49a9-b880-ea80fdb133f5SPL ID 322a4cec-4797-49a9-b880-ea80fdb133f5SPL set ID 640602f9-a7df-46f0-a9b1-19c471008beeRxCUI 1726673, 1726676UNII 7DP3NTV15T
- Pharmacologic class
- Cytoprotective Agent
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
N471288010610followed by a unit qualifier and the quantityPackage 71288-0106-10. 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 Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin for Injection, USP is poorer in patients with previously irradiated head and neck cancer. Lymphomas: Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratoc…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205030
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 |
|---|---|---|---|---|
| Bleomycin | Bleomycin sulfate 15 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | NorthStar Rx LLC | 16714-886 |
| Bleomycin | Bleomycin sulfate 30 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | NorthStar Rx LLC | 16714-908 |
| Bleomycinbleomycin sulfate | Bleomycin sulfate 30 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-107 |