Prescription drug · ANDA
Bleomycin NDC 16714-886
Bleomycin sulfate 15 [USP'U]/1 · Powder, For solution · Intramuscular, Intrapleural, Intravenous, Subcutaneous · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-886-01 | 1671408860116714088601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-886-01) / 15 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 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
- Active ingredients
- Bleomycin sulfate — 15 [USP'U]/1
- Dosage form
- Powder, For solution
- Route
- Intramuscular, Intrapleural, Intravenous, Subcutaneous
- Labeler
- NorthStar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205030
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-886_c3601b94-30e6-4651-a9da-f6a70e907314SPL ID c3601b94-30e6-4651-a9da-f6a70e907314SPL set ID 6824b1e1-e5fa-4371-ade9-1346e12ab0c7RxCUI 1726673, 1726676UNII 7DP3NTV15TUPC 0316714886015, 0316714908014
- 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
N416714088601followed by a unit qualifier and the quantityPackage 16714-0886-01. 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 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.
About NDC 16714-886
- What is NDC 16714-886?
- 16714-886 is the product NDC for Bleomycin, Bleomycin sulfate 15 [USP'U]/1 powder, for solution, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bleomycin.
- What is the active ingredient?
- Bleomycin sulfate.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bleomycin?
- 11 other product NDCs are listed under this name. See all Bleomycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bleomycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bleomycin | Bleomycin sulfate 30 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | NorthStar Rx LLC | 16714-908 | 16714-0908-01 |
| Bleomycinbleomycin sulfate | Bleomycin sulfate 15 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-106 | 71288-0106-10 |
| Bleomycinbleomycin sulfate | Bleomycin sulfate 30 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-107 | 71288-0107-20 |
| Bleomycin | Bleomycin sulfate 30 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hospira, Inc. | 0409-0323 | 00409-0323-20 |
| Bleomycin | Bleomycin sulfate 15 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9240 | 00143-9240-01 |
| Bleomycin | Bleomycin sulfate 30 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9241 | 00143-9241-01 |
| Bleomycin | Bleomycin sulfate 15 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hospira, Inc. | 0409-0332 | 00409-0332-20 |
| Bleomycinbleomycin sulfate | Bleomycin sulfate 15 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-136 | 63323-0136-10 |
| Bleomycinbleomycin sulfate | Bleomycin sulfate 30 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-137 | 63323-0137-20 |
| Bleomycin | Bleomycin sulfate 15 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hospira, Inc. | 61703-332 | 61703-0332-18 |
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 30 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | NorthStar Rx LLC | 16714-908 |
| Bleomycinbleomycin sulfate | Bleomycin sulfate 15 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-106 |
| Bleomycinbleomycin sulfate | Bleomycin sulfate 30 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-107 |