NDC codes

FDA NDC Directory
Product NDC (as listed)67308-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67308-0101Add 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 NDC11-digit (billing)PackageCopy
67308-101-0167308010101673080101011 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULEMarketed from Sep 4, 2000
67308-101-0267308010102673080101022 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
67308-101-0667308010106673080101066 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
Labeler
Sun Pharmaceutical Industries, IncNDC labeler code 67308
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

N467308010101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 67308-101

What is NDC 67308-101?
67308-101 is the product NDC for Levulan Kerastick (aminolevulinic acid hydrochloride) kit, listed with the FDA by Sun Pharmaceutical Industries, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Levulan Kerastick (Aminolevulinic acid hydrochloride).
Who is the labeler?
Sun Pharmaceutical Industries, Inc, NDC labeler code 67308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levulan Kerastick?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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