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United States · US · US:68462-309_fbb3fa97-10f6-482a-8d60-e67563ec2bfb
Norgestimate and Ethinyl Estradiol
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462309293 BLISTER PACK in 1 CARTON (68462-309-29) / 1 KIT in 1 BLISTER PACK (68462-309-84)
Annotations
Orange Book
A200538
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"35c6507c-555a-45ed-aaf6-8695831de71a": {
"match": "brand_token",
"title": "NORGESTIMATE AND ETHINYL ESTRADIOL KIT [A-S MEDICATION SOLUTIONS]",
"spl_version": "12",
"published_date": "2026-04-01"
}
},
"productid": "68462-309_fbb3fa97-10f6-482a-8d60-e67563ec2bfb",
"productndc": "68462-309",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "200538",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;0.25MG",
"product_no": "001",
"approval_date": "Apr 5, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Norgestimate and Ethinyl Estradiol",
"active_ingred_unit": null,
"application_number": "ANDA200538",
"marketing_category": "ANDA",
"nonproprietary_name": "Norgestimate and Ethinyl Estradiol",
"start_marketing_date": "20120406",
"active_numerator_strength": null
}Access this data programmatically
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