Prescription drug · ANDA
Isosulfan Blue NDC 72078-070
Isosulfan blue 10 mg/mL · Injection, Solution · Subcutaneous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72078-070-03 | 7207800700372078007003 | 1 SYRINGE in 1 CARTON (72078-070-03) / 3 mL in 1 SYRINGEMarketed from Feb 1, 2026 |
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
- Mylan Institutional LLCNDC labeler code 72078
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090874
- Marketing start
- Listing expires
- Identifiers
- Product ID 72078-070_17faad04-f361-4b65-8f37-964efd5c74e0SPL ID 17faad04-f361-4b65-8f37-964efd5c74e0SPL set ID 0391e544-3633-48df-9f3a-ed16183125b1UNII 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.
- NDC on a medical claim
N472078007003followed by a unit qualifier and the quantityPackage 72078-0070-03. 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 .
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.
About NDC 72078-070
- What is NDC 72078-070?
- 72078-070 is the product NDC for Isosulfan Blue, Isosulfan blue 10 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. 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?
- Mylan Institutional LLC, NDC labeler code 72078. 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.
Related NDCs: other Isosulfan Blue products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Novadoz Pharmaceuticals LLC | 72205-195 | 72205-0195-0172205-0195-02 |
| Isosulfan Blue | Isosulfan blue 10 mg/mL | Injection, SolutionSubcutaneous | Meitheal Pharmaceuticals Inc. | 71288-805 | 71288-0805-06 |
| 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 |
Other NDCs under ANDA 090874
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 |
|---|---|---|---|---|
| Isosulfan Blue | Isosulfan blue 10 mg/mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-220 |
| Isosulfan Blue | Isosulfan blue 10 mg/mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 72078-069 |