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United States · US · US:0113-8101_fb2ad1e4-4e8a-4cee-a6e8-a823401dd8fe
Opill
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerL. Perrigo Company
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1101138101011 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK
- ndc1101138101033 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK
- ndc1101138101044 BLISTER PACK in 1 PACKAGE (0113-8101-04) / 28 TABLET in 1 BLISTER PACK
- ndc1101138101066 BLISTER PACK in 1 CARTON (0113-8101-06) / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
3J8Q1747Z2
NORGESTREL
RxCUI 7518
Orange Book
N017031
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3J8Q1747Z2",
"rxcui": "7518",
"inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N;WWYNJERNGUHSAO-XHCJJCCMSA-N",
"display_name": "NORGESTREL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"303264da-c919-e0ce-e063-6394a90a4cc7": {
"match": "brand_token",
"title": "OPILL (NORGESTREL) TABLET [REDPHARM DRUG]",
"spl_version": "3",
"published_date": "2025-12-26"
}
},
"productid": "0113-8101_fb2ad1e4-4e8a-4cee-a6e8-a823401dd8fe",
"productndc": "0113-8101",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "017031",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.075MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NORGESTREL",
"proprietary_name": "Opill",
"active_ingred_unit": "mg/1",
"application_number": "NDA017031",
"marketing_category": "NDA",
"nonproprietary_name": "norgestrel",
"start_marketing_date": "20240304",
"active_numerator_strength": ".075"
}Access this data programmatically
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