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United States · US · US:51862-028_bf6c876c-12de-48e8-a9f2-cf74ee3338f1
Lutera
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
Orange Book
A076625
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"47fc432b-2259-47d2-bba9-5e3aae583990": {
"match": "brand_token",
"title": "LUTERA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [DR. REDDY’S LABORATORIES INC.]",
"spl_version": "1",
"published_date": "2026-02-16"
}
},
"productid": "51862-028_bf6c876c-12de-48e8-a9f2-cf74ee3338f1",
"productndc": "51862-028",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "076625",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB1",
"strength": "0.02MG;0.1MG",
"product_no": "001",
"approval_date": "Nov 18, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Lutera",
"active_ingred_unit": null,
"application_number": "ANDA076625",
"marketing_category": "ANDA",
"nonproprietary_name": "levonorgestrel and ethinyl estradiol",
"start_marketing_date": "20160803",
"active_numerator_strength": null
}Access this data programmatically
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