Prescription drug · NDA
Levulan Kerastick (aminolevulinic acid hydrochloride) NDC 67308-101
Kit · Sun Pharmaceutical Industries, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67308-101-01 | 67308010101 | 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULEMarketed from Sep 4, 2000 | |
| 67308-101-02 | 67308010102 | 2 APPLICATOR in 1 CARTON (67308-101-02) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULEMarketed from Dec 20, 2000 | |
| 67308-101-06 | 67308010106 | 6 APPLICATOR in 1 CARTON (67308-101-06) / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULEMarketed from Sep 24, 2000 |
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)
- Levulan Kerastick
- Generic name (nonproprietary)
- aminolevulinic acid hydrochloride
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020965
- Marketing start
- Listing expires
- Identifiers
- Product ID 67308-101_21ef2c6b-8abc-8bcf-e063-6294a90ae9e1SPL ID 21ef2c6b-8abc-8bcf-e063-6294a90ae9e1SPL set ID e45cc371-9ebc-4904-12bc-65cb4e2817adRxCUI 762672, 762674
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
N467308010101followed by a unit qualifier and the quantityPackage 67308-0101-01. 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 .
Indications (excerpt from the label)
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities. ( 1 )
Excerpt only. Read the full label for complete information.