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United States · US · US:65862-865_e44389c6-fdd2-408e-8bfe-324842c36d76
Iclevia
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165862865833 POUCH in 1 CARTON (65862-865-83) / 1 BLISTER PACK in 1 POUCH (65862-865-94) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A206850
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"00657f4e-9df8-4f58-91a0-eff5a467f988": {
"match": "brand_token",
"title": "ICLEVIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
"spl_version": "9",
"published_date": "2024-08-05"
}
},
"productid": "65862-865_e44389c6-fdd2-408e-8bfe-324842c36d76",
"productndc": "65862-865",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "206850",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03MG;0.15MG",
"product_no": "001",
"approval_date": "Jun 29, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Iclevia",
"active_ingred_unit": null,
"application_number": "ANDA206850",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
"start_marketing_date": "20180629",
"active_numerator_strength": null
}Access this data programmatically
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