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United States · US · US:68180-868_3c3a2ddd-8711-416c-813e-63c64f579ac2
DROSPIRENONE AND ETHINYL ESTRADIOL
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168180868733 POUCH in 1 CARTON (68180-868-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (68180-913-74) * 21 TABLET in 1 BLISTER PACK (68180-912-74)
Annotations
Orange Book
A201663
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"9187a357-e95d-4733-9627-f19522b86373": {
"match": "brand_token",
"title": "DROSPIRENONE AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
"spl_version": "3",
"published_date": "2026-05-15"
}
},
"productid": "68180-868_3c3a2ddd-8711-416c-813e-63c64f579ac2",
"productndc": "68180-868",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "201663",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG;0.03MG",
"product_no": "001",
"approval_date": "Dec 18, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "DROSPIRENONE AND ETHINYL ESTRADIOL",
"active_ingred_unit": null,
"application_number": "ANDA201663",
"marketing_category": "ANDA",
"nonproprietary_name": "DROSPIRENONE AND ETHINYL ESTRADIOL",
"start_marketing_date": "20220415",
"active_numerator_strength": null
}Access this data programmatically
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