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United States · US · US:63629-5628_45cd9330-d3a0-4504-8487-26c79b91f826
Junel
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163629562816 POUCH in 1 CARTON (63629-5628-1) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A076081
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"93a2f8c9-3550-42ec-8f76-3ac9badf4bb2": {
"match": "brand_token",
"title": "JUNEL FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "18",
"published_date": "2026-05-25"
}
},
"productid": "63629-5628_45cd9330-d3a0-4504-8487-26c79b91f826",
"productndc": "63629-5628",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "076081",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.02MG;1MG",
"product_no": "001",
"approval_date": "Sep 18, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Junel",
"active_ingred_unit": null,
"application_number": "ANDA076081",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
"start_marketing_date": "20030918",
"active_numerator_strength": null
}Access this data programmatically
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