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United States · US · US:72789-450_525a6380-51e2-1cdc-e063-6394a90a0a35
Junel
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11727894507928 BLISTER PACK in 1 POUCH (72789-450-79) / 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": "72789-450_525a6380-51e2-1cdc-e063-6394a90a0a35",
"productndc": "72789-450",
"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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