Prescription drug · ANDA
Indocyanine Green (Indocyanine green and water) NDC 70100-424
Kit · Renew Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70100-424-02 | 7010004240270100042402 | 6 PACKAGE in 1 CARTON (70100-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)Marketed from Jan 1, 2008 |
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)
- Indocyanine Green
- Generic name (nonproprietary)
- indocyanine green and water
- Dosage form
- Kit
- Labeler
- Renew Pharmaceuticals LimitedNDC labeler code 70100
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040811
- Marketing start
- Listing expires
- Identifiers
- Product ID 70100-424_3abdfd10-c4e6-472e-b4eb-d4953f029132SPL ID 3abdfd10-c4e6-472e-b4eb-d4953f029132SPL set ID a6f24787-c243-445a-9c55-7c7479b292d9
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.
- NDC on a medical claim
N470100042402followed by a unit qualifier and the quantityPackage 70100-0424-02. 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)
Indocyanine Green for injection is indicated: Indocyanine Green for injection is an optical imaging agent indicated for: • Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older ( 1.1 ) • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older ( 1.2 ) • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine can…
Excerpt only. Read the full label for complete information.
About NDC 70100-424
- What is NDC 70100-424?
- 70100-424 is the product NDC for Indocyanine Green kit, listed with the FDA by Renew Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Indocyanine Green (Indocyanine Green and Water).
- Who is the labeler?
- Renew Pharmaceuticals Limited, NDC labeler code 70100. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Indocyanine Green?
- 3 other product NDCs are listed under this name. See all Indocyanine Green NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Indocyanine Green products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Indocyanine green | — | Kit | Zydus Pharmaceuticals USA Inc. | 70710-2018 | 70710-2018-03 |
| Indocyanine Green | — | Kit | Zydus Lifesciences Limited | 70771-1961 | 70771-1961-03 |
| Indocyanine Greenindocyanine green and water | — | Kit | Olympus America, Inc. | 73624-424 | 73624-0424-02 |
Other NDCs under ANDA 040811
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 |
|---|---|---|---|---|
| Indocyanine Greenindocyanine green and water | — | Kit | Olympus America, Inc. | 73624-424 |