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United States · US · US:55741-005_eb48cc50-744a-4e77-b520-18a9522530ae
Lutera
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy�s Laboratories Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1155741005066 BLISTER PACK in 1 CARTON (55741-005-06) / 1 KIT in 1 BLISTER PACK
- ndc1155741005281 BLISTER PACK in 1 PACKET (55741-005-28) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A090721
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": "55741-005_eb48cc50-744a-4e77-b520-18a9522530ae",
"productndc": "55741-005",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "090721",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "0.02MG;0.1MG",
"product_no": "001",
"approval_date": "Mar 28, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Lutera",
"active_ingred_unit": null,
"application_number": "ANDA090721",
"marketing_category": "ANDA",
"nonproprietary_name": "levonorgestrel and ethinyl estradiol",
"start_marketing_date": "20260213",
"active_numerator_strength": null
}Access this data programmatically
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