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United States · US · US:0555-9064_a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3
Kelnor 1/35
Orange Book
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105559064586 POUCH in 1 CARTON (0555-9064-58) / 1 BLISTER PACK in 1 POUCH (0555-9064-79) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A076785
AB
Raw payload (JSON)
{
"route": null,
"productid": "0555-9064_a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3",
"productndc": "0555-9064",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "076785",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;1MG",
"product_no": "001",
"approval_date": "May 23, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Kelnor 1/35",
"active_ingred_unit": null,
"application_number": "ANDA076785",
"marketing_category": "ANDA",
"nonproprietary_name": "Ethynodiol Diacetate and Ethinyl Estradiol",
"start_marketing_date": "20050620",
"active_numerator_strength": null
}Access this data programmatically
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