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United States · US · US:65162-475_764f6075-288a-4435-b148-35589e5e5835
Norethindrone Acetate
Orange BookUNIISPLATC G03DC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG03DC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11651624750330 TABLET in 1 BOTTLE (65162-475-03)
- ndc11651624750550 TABLET in 1 BOTTLE (65162-475-05)
- ndc11651624750990 TABLET in 1 BOTTLE (65162-475-09)
- ndc116516247550500 TABLET in 1 BOTTLE (65162-475-50)
Annotations
UNII (FDA Substance ID)
9S44LIC7OJ
NORETHINDRONE ACETATE
RxCUI 31983
Orange Book
A200275
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9S44LIC7OJ",
"rxcui": "31983",
"inchikey": "IMONTRJLAWHYGT-ZCPXKWAGSA-N",
"display_name": "NORETHINDRONE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
"match": "brand_token",
"title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
"spl_version": "7",
"published_date": "2026-03-27"
}
},
"productid": "65162-475_764f6075-288a-4435-b148-35589e5e5835",
"productndc": "65162-475",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "200275",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jul 30, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NORETHINDRONE ACETATE",
"proprietary_name": "Norethindrone Acetate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200275",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone",
"start_marketing_date": "20090701",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G03DC02.
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