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United States · US · US:0555-9131_7aced6b3-f763-4234-9b64-2ffdae162347
OCELLA
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTEVA PHARMACEUTICALS USA, INC.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105559131673 BLISTER PACK in 1 PACKAGE (0555-9131-67) / 1 KIT in 1 BLISTER PACK (0555-9131-79)
Annotations
Orange Book
N021098
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37": {
"match": "brand_token",
"title": "OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "28",
"published_date": "2026-03-05"
}
},
"productid": "0555-9131_7aced6b3-f763-4234-9b64-2ffdae162347",
"productndc": "0555-9131",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "021098",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "3MG;0.03MG",
"product_no": "001",
"approval_date": "May 11, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "OCELLA",
"active_ingred_unit": null,
"application_number": "NDA021098",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "drospirenone and ethinyl estradiol",
"start_marketing_date": "20010611",
"active_numerator_strength": null
}Access this data programmatically
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