levulan kerastick

Generic: aminolevulinic acid hydrochloride

Labeler: sun pharmaceutical industries, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name levulan kerastick
Generic Name aminolevulinic acid hydrochloride
Labeler sun pharmaceutical industries, inc
Dosage Form KIT
Manufacturer
Sun Pharmaceutical Industries, Inc

Identifiers & Regulatory

Product NDC 67308-101
Product ID 67308-101_21ef2c6b-8abc-8bcf-e063-6294a90ae9e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020965
Listing Expiration 2026-12-31
Marketing Start 2000-09-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67308101
Hyphenated Format 67308-101

Supplemental Identifiers

RxCUI
762672 762674

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name levulan kerastick (source: ndc)
Generic Name aminolevulinic acid hydrochloride (source: ndc)
Application Number NDA020965 (source: ndc)

Resolved Composition

Strengths
  • 354 mg
  • 20 %
  • 1.5 ml
source: label
Packaging
  • 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE
  • 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 AMPULE
  • 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 AMPULE
source: ndc

Packages (3)

67308-101-01 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE 67308-101-02 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 AMPULE 67308-101-06 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 AMPULE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

LEVULAN KERASTICK ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "21ef2c6b-8abc-8bcf-e063-6294a90ae9e1", "openfda": {"rxcui": ["762672", "762674"], "spl_set_id": ["e45cc371-9ebc-4904-12bc-65cb4e2817ad"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 APPLICATOR (67308-101-01)  *  1.5 mL in 1 AMPULE *  1.5 mL in 1 AMPULE", "package_ndc": "67308-101-01", "marketing_start_date": "20000904"}, {"sample": false, "description": "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 AMPULE", "package_ndc": "67308-101-02", "marketing_start_date": "20001220"}, {"sample": false, "description": "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 AMPULE", "package_ndc": "67308-101-06", "marketing_start_date": "20000924"}], "brand_name": "LEVULAN KERASTICK", "product_id": "67308-101_21ef2c6b-8abc-8bcf-e063-6294a90ae9e1", "dosage_form": "KIT", "product_ndc": "67308-101", "generic_name": "aminolevulinic acid hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVULAN KERASTICK", "application_number": "NDA020965", "marketing_category": "NDA", "marketing_start_date": "20000904", "listing_expiration_date": "20261231"}