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United States · US · US:52544-629_d98a1fdf-3727-41aa-9974-9a7680441740
Nora BE
Orange BookUNIISPLATC G03DC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeG03DC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1152544629286 PACKAGE in 1 CARTON (52544-629-28) / 28 TABLET in 1 PACKAGE
Annotations
UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
N017060
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "T18F433X4S",
"rxcui": "7514",
"inchikey": "VIKNJXKGJWUCNN-XGXHKTLJSA-N",
"display_name": "NORETHINDRONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"426ac898-7745-4645-bf9b-bae319e260e8": {
"match": "brand_token",
"title": "NORA BE (NORETHINDRONE) TABLET [TEVA PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2024-11-04"
}
},
"productid": "52544-629_d98a1fdf-3727-41aa-9974-9a7680441740",
"productndc": "52544-629",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "017060",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB1",
"strength": "0.35MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NORETHINDRONE",
"proprietary_name": "Nora BE",
"active_ingred_unit": "mg/1",
"application_number": "NDA017060",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Norethindrone",
"start_marketing_date": "20050512",
"active_numerator_strength": ".35"
}Related drugs
Other records sharing ATC code G03DC02.
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