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United States · US · US:0480-3493_6cb4094e-229d-480f-884f-40b4a4bb407b
Cryselle
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104803493166 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22)
Annotations
Orange Book
A075840
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"f73ece43-6b5f-4abb-ba6d-4d62775f2f8e": {
"match": "brand_token",
"title": "CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS]",
"spl_version": "1",
"published_date": "2026-03-05"
}
},
"productid": "0480-3493_6cb4094e-229d-480f-884f-40b4a4bb407b",
"productndc": "0480-3493",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "075840",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03MG;0.3MG",
"product_no": "001",
"approval_date": "Nov 30, 2001"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.03MG;0.3MG",
"product_no": "002",
"approval_date": "Nov 30, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Cryselle",
"active_ingred_unit": null,
"application_number": "ANDA075840",
"marketing_category": "ANDA",
"nonproprietary_name": "Norgestrel and Ethinyl Estradiol",
"start_marketing_date": "20251212",
"active_numerator_strength": null
}Access this data programmatically
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