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United States · US · US:67308-101_21ef2c6b-8abc-8bcf-e063-6294a90ae9e1
LEVULAN KERASTICK
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1167308101011 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE
- ndc1167308101022 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
- ndc1167308101066 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
Annotations
Orange Book
N020965
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"e45cc371-9ebc-4904-12bc-65cb4e2817ad": {
"match": "brand_token",
"title": "LEVULAN KERASTICK (AMINOLEVULINIC ACID HYDROCHLORIDE) KIT [SUN PHARMACEUTICAL INDUSTRIES, INC]",
"spl_version": "21",
"published_date": "2024-09-13"
}
},
"productid": "67308-101_21ef2c6b-8abc-8bcf-e063-6294a90ae9e1",
"productndc": "67308-101",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "020965",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20%",
"product_no": "001",
"approval_date": "Dec 3, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "LEVULAN KERASTICK",
"active_ingred_unit": null,
"application_number": "NDA020965",
"marketing_category": "NDA",
"nonproprietary_name": "aminolevulinic acid hydrochloride",
"start_marketing_date": "20000904",
"active_numerator_strength": null
}Access this data programmatically
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