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United States · US · US:0555-9012_5157d13b-a384-46cb-9e9e-f3691d4f9072
Nortrel 7/7/7
Orange BookSPL
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
- ndc1105559012586 POUCH in 1 CARTON (0555-9012-58) / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A075478
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"140c50d6-c931-423a-9aa0-526eae7ab93c": {
"match": "brand_token",
"title": "NORTREL 21 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "16",
"published_date": "2026-01-28"
}
},
"productid": "0555-9012_5157d13b-a384-46cb-9e9e-f3691d4f9072",
"productndc": "0555-9012",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "075478",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG",
"product_no": "001",
"approval_date": "Aug 30, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG",
"product_no": "002",
"approval_date": "Aug 30, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Nortrel 7/7/7",
"active_ingred_unit": null,
"application_number": "ANDA075478",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone and Ethinyl Estradiol",
"start_marketing_date": "20030102",
"active_numerator_strength": null
}Access this data programmatically
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