What is NDC 71288-116?

71288-116 is the product NDC for Busulfan, Busulfan 6 mg/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Busulfan?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Busulfan NDC 71288-116 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0116Add 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 NDC	11-digit (billing)	Package	Copy
71288-116-11	7128801161171288011611	8 VIAL, SINGLE-DOSE in 1 CARTON (71288-116-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-116-10)Marketed from Oct 23, 2020

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): Busulfan
Generic name (nonproprietary): busulfan
Active ingredients: Busulfan — 6 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Meitheal Pharmaceuticals Inc.NDC labeler code 71288
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212127
Marketing start: Oct 23, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 71288-116_ebe3b619-0e7a-42fc-bb7b-f219b900597bSPL ID ebe3b619-0e7a-42fc-bb7b-f219b900597bSPL set ID 6e68ab21-19bd-4b7e-b8d0-bf284d5af183RxCUI 253113UNII G1LN9045DK
Pharmacologic class: Alkylating Drug

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

N471288011611 followed by a unit qualifier and the quantity

Package 71288-0116-11. 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 Jun 14, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Busulfan Injection is an alkylating drug indicated for: Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML) ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71288-116

What is NDC 71288-116?: 71288-116 is the product NDC for Busulfan, Busulfan 6 mg/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Busulfan.
What is the active ingredient?: Busulfan.
Who is the labeler?: Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Busulfan?: 7 other product NDCs are listed under this name. See all Busulfan 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 Busulfan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Busulfan	Busulfan 6 mg/mL	Injection, SolutionIntravenous	Eugia US LLC	55150-395	55150-0395-08
Busulfan	Busulfan 6 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-158	71288-0158-96
Busulfan	Busulfan 6 mg/mL	InjectionIntravenous	Accord Healthcare, Inc	16729-351	16729-0351-92
Busulfan	Busulfan 6 mg/mL	Injection, SolutionIntravenous	Hospira, Inc.	0409-1112	00409-1112-01
Busulfan	Busulfan 6 mg/mL	InjectionIntravenous	Amneal Pharmaceuticals LLC	70121-1244	70121-1244-07
Busulfan	Busulfan 6 mg/mL	InjectionIntravenous	Pharmascience Inc.	51817-170	51817-0170-01
Busulfan	Busulfan 6 mg/mL	Injection, Solution, ConcentrateIntravenous	Sagent Pharmaceuticals	25021-241	25021-0241-10

Other NDCs under ANDA 212127

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

FDA NDC Directory listings under ANDA 212127
Product	Strength	Form · route	Labeler	Product NDC
Busulfan	Busulfan 6 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-158