NDC codes

FDA NDC Directory
Product NDC (as listed)16714-886Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0886Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
16714-886-0116714088601167140886011 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.

How CPT relates to drug billing

NDC on a medical claim

N416714088601 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bleomycin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BleomycinBleomycin sulfate 30 [USP'U]/1Powder, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousNorthStar Rx LLC16714-90816714-0908-01
Bleomycinbleomycin sulfateBleomycin sulfate 15 [USP'U]/1Powder, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousMeitheal Pharmaceuticals Inc.71288-10671288-0106-10
Bleomycinbleomycin sulfateBleomycin sulfate 30 [USP'U]/1Powder, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousMeitheal Pharmaceuticals Inc.71288-10771288-0107-20
BleomycinBleomycin sulfate 30 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousHospira, Inc.0409-032300409-0323-20
BleomycinBleomycin sulfate 15 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0143-924000143-9240-01
BleomycinBleomycin sulfate 30 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0143-924100143-9241-01
BleomycinBleomycin sulfate 15 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousHospira, Inc.0409-033200409-0332-20
Bleomycinbleomycin sulfateBleomycin sulfate 15 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousFresenius Kabi USA, LLC63323-13663323-0136-10
Bleomycinbleomycin sulfateBleomycin sulfate 30 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousFresenius Kabi USA, LLC63323-13763323-0137-20
BleomycinBleomycin sulfate 15 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousHospira, Inc.61703-33261703-0332-18

All 12 Bleomycin NDCs

Other NDCs under ANDA 205030

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205030
ProductStrengthForm · routeLabelerProduct NDC
BleomycinBleomycin sulfate 30 [USP'U]/1Powder, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousNorthStar Rx LLC16714-908
Bleomycinbleomycin sulfateBleomycin sulfate 15 [USP'U]/1Powder, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousMeitheal Pharmaceuticals Inc.71288-106
Bleomycinbleomycin sulfateBleomycin sulfate 30 [USP'U]/1Powder, For solutionIntramuscular, Intrapleural, Intravenous, SubcutaneousMeitheal Pharmaceuticals Inc.71288-107

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