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United States · US · US:0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150
Sprintec
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
- ndc1105559016586 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A075804
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"90240210-0bca-4a55-99dc-19f2b40d8e3f": {
"match": "brand_token",
"title": "SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PREFERRED PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2025-09-29"
}
},
"productid": "0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150",
"productndc": "0555-9016",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "075804",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;0.25MG",
"product_no": "001",
"approval_date": "Sep 25, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Sprintec",
"active_ingred_unit": null,
"application_number": "ANDA075804",
"marketing_category": "ANDA",
"nonproprietary_name": "Norgestimate and Ethinyl Estradiol",
"start_marketing_date": "20020926",
"active_numerator_strength": null
}Access this data programmatically
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