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United States · US · US:16714-404_12f60f95-d164-4964-bf6a-dc3cfb42bac0
PIMTREA
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthstar Rx LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1116714404011 BLISTER PACK in 1 PACKET (16714-404-01) / 1 KIT in 1 BLISTER PACK
- ndc1116714404021 BLISTER PACK in 1 CARTON (16714-404-02) / 1 KIT in 1 BLISTER PACK
- ndc1116714404033 BLISTER PACK in 1 CARTON (16714-404-03) / 1 KIT in 1 BLISTER PACK
- ndc1116714404046 BLISTER PACK in 1 CARTON (16714-404-04) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A091247
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"b716fd2a-b186-447a-85bd-6302284d14e5": {
"match": "brand_token",
"title": "PIMTREA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]",
"spl_version": "8",
"published_date": "2025-12-10"
}
},
"productid": "16714-404_12f60f95-d164-4964-bf6a-dc3cfb42bac0",
"productndc": "16714-404",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "091247",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.15MG,N/A;0.02MG,0.01MG",
"product_no": "001",
"approval_date": "Aug 1, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "PIMTREA",
"active_ingred_unit": null,
"application_number": "ANDA091247",
"marketing_category": "ANDA",
"nonproprietary_name": "desogestrel/ethinyl estradiol and ethinyl estradiol",
"start_marketing_date": "20130801",
"active_numerator_strength": null
}Access this data programmatically
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