Prescription drug · ANDA
Bleomycin NDC 0143-9241
Bleomycin sulfate 30 [USP'U]/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intrapleural, Intravenous, Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9241-01 | 0014392410100143924101 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9241-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Jan 9, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 30 [USP'U]/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intrapleural, Intravenous, Subcutaneous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065042
- Marketing start
- Listing expires
- Identifiers
- Product ID 0143-9241_c8047994-3b3a-4e16-809b-786e47014fe9SPL ID c8047994-3b3a-4e16-809b-786e47014fe9SPL set ID cccfb763-79fa-4186-89fb-d8d061d3c161RxCUI 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
N400143924101followed by a unit qualifier and the quantityPackage 00143-9241-01. 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 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 for Injection, USP has also been shown to be useful in the management of: Malignant Pleural Effusion Bleomycin is effe…
Excerpt only. Read the full label for complete information.
About NDC 0143-9241
- What is NDC 0143-9241?
- 0143-9241 is the product NDC for Bleomycin, Bleomycin sulfate 30 [USP'U]/1 injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 15 [USP'U]/1 | Powder, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | NorthStar Rx LLC | 16714-886 | 16714-0886-01 |
| 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 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 065042
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 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9240 |