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United States · US · US:68462-305_5a1f7007-bfeb-4899-a1a3-b3c005cbcabb
Norethindrone
Orange BookUNIISPLATC G03DC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeG03DC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462305293 POUCH in 1 CARTON (68462-305-29) / 28 TABLET in 1 POUCH (68462-305-84)
Annotations
UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A091209
AB2
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": {
"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": "68462-305_5a1f7007-bfeb-4899-a1a3-b3c005cbcabb",
"productndc": "68462-305",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091209",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "0.35MG",
"product_no": "001",
"approval_date": "Jul 22, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NORETHINDRONE",
"proprietary_name": "Norethindrone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091209",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone",
"start_marketing_date": "20101103",
"active_numerator_strength": ".35"
}Related drugs
Other records sharing ATC code G03DC02.
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