Prescription drug · ANDA
Bleomycin NDC 61703-332
Bleomycin sulfate 15 [USP'U]/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intrapleural, Intravenous, Subcutaneous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61703-332-18 | 61703033218 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-332-18) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Apr 11, 2000 |
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
- Active ingredients
- Bleomycin sulfate — 15 [USP'U]/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intrapleural, Intravenous, Subcutaneous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065031
- Marketing start
- Listing expires
- Identifiers
- Product ID 61703-332_6615dbd2-3bb4-40b5-8599-aa46bc0bc488SPL ID 6615dbd2-3bb4-40b5-8599-aa46bc0bc488SPL set ID 905e0984-2ce3-481c-b1a0-0ef0a616479aRxCUI 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
N461703033218followed by a unit qualifier and the quantityPackage 61703-0332-18. 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 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 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 teratocarcinoma. Bleomycin has als…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065031
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 30 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hospira, Inc. | 61703-323 |
| Bleomycin | Bleomycin sulfate 30 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hospira, Inc. | 0409-0323 |
| Bleomycin | Bleomycin sulfate 15 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hospira, Inc. | 0409-0332 |