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United States · US · US:16714-464_4feaf19e-05de-4481-8e00-668b6f1f3870
Juleber
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthstar Rx LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1116714464011 BLISTER PACK in 1 PACKET (16714-464-01) / 1 KIT in 1 BLISTER PACK
- ndc1116714464021 BLISTER PACK in 1 CARTON (16714-464-02) / 1 KIT in 1 BLISTER PACK
- ndc1116714464033 BLISTER PACK in 1 CARTON (16714-464-03) / 1 KIT in 1 BLISTER PACK
- ndc1116714464046 BLISTER PACK in 1 CARTON (16714-464-04) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A091234
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"de9a2d1b-15f6-453f-b36b-1c2a43c4918d": {
"match": "brand_token",
"title": "JULEBER (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]",
"spl_version": "11",
"published_date": "2025-11-20"
}
},
"productid": "16714-464_4feaf19e-05de-4481-8e00-668b6f1f3870",
"productndc": "16714-464",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "091234",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.15MG;0.03MG",
"product_no": "001",
"approval_date": "Jul 12, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Juleber",
"active_ingred_unit": null,
"application_number": "ANDA091234",
"marketing_category": "ANDA",
"nonproprietary_name": "Desogestrel and Ethinyl Estradiol",
"start_marketing_date": "20130712",
"active_numerator_strength": null
}Access this data programmatically
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