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United States · US · US:63187-458_5248afaf-9c38-4cc2-a25b-53d93491f698
Tri-Sprintec
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163187458286 POUCH in 1 CARTON (63187-458-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A075808
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"1f8b9aad-f31f-4cda-861d-c08a977fc923": {
"match": "brand_token",
"title": "TRI-SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "8",
"published_date": "2025-10-03"
}
},
"productid": "63187-458_5248afaf-9c38-4cc2-a25b-53d93491f698",
"productndc": "63187-458",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "075808",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG",
"product_no": "001",
"approval_date": "Dec 29, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Tri-Sprintec",
"active_ingred_unit": null,
"application_number": "ANDA075808",
"marketing_category": "ANDA",
"nonproprietary_name": "norgestimate and ethinyl estradiol",
"start_marketing_date": "20031229",
"active_numerator_strength": null
}Access this data programmatically
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