What is NDC 71288-805?

71288-805 is the product NDC for Isosulfan Blue, Isosulfan blue 10 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 Isosulfan Blue?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isosulfan Blue NDC 71288-805 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-805Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0805Add 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
71288-805-06	7128808050671288080506	6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05)Marketed from Nov 3, 2021

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): Isosulfan Blue
Generic name (nonproprietary): isosulfan blue
Active ingredients: Isosulfan blue — 10 mg/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Meitheal Pharmaceuticals Inc.NDC labeler code 71288
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213130
Marketing start: Nov 3, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 71288-805_1c9d3281-9ee0-4e8c-9d36-7736ada64138SPL ID 1c9d3281-9ee0-4e8c-9d36-7736ada64138SPL set ID d36ae5af-6351-497a-9151-82bcb2c62fa0UNII 39N9K8S2A4

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

N471288080506 followed by a unit qualifier and the quantity

Package 71288-0805-06. 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 Oct 12, 2021.

Indications (excerpt from the label)

Isosulfan Blue Injection 1% upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities ( 1.1 ). 1.1 Lymphatic Vessel Delineation Isosulfan Blue Injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71288-805

What is NDC 71288-805?: 71288-805 is the product NDC for Isosulfan Blue, Isosulfan blue 10 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?: Isosulfan Blue.
What is the active ingredient?: Isosulfan blue.
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 Isosulfan Blue?: 7 other product NDCs are listed under this name. See all Isosulfan Blue 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 Isosulfan Blue NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isosulfan Blue	Isosulfan blue 10 mg/mL	Injection, SolutionSubcutaneous	Somerset Therapeutics, LLC	70069-221	70069-0221-06
Isosulfan Blue	Isosulfan blue 10 mg/mL	Injection, SolutionSubcutaneous	Devatis, Inc.	73043-093	73043-0093-06
Isosulfan Blue	Isosulfan blue 10 mg/mL	Injection, SolutionSubcutaneous	Mylan Institutional LLC	72078-069	72078-0069-01
Isosulfan Blue	Isosulfan blue 10 mg/mL	Injection, SolutionSubcutaneous	Mylan Institutional LLC	72078-070	72078-0070-03
Isosulfan blue	Isosulfan blue 10 mg/mL	Injection, SolutionSubcutaneous	Novadoz Pharmaceuticals LLC	72205-195	72205-0195-0172205-0195-02
Isosulfan Blue	Isosulfan blue 50 mg/5mL	Injection, SolutionSubcutaneous	Eugia US LLC	55150-240	55150-0240-06
Isosulfan Blue	Isosulfan blue 10 mg/mL	Injection, SolutionSubcutaneous	Mylan Institutional LLC	67457-220	67457-0220-05