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United States · US · US:16714-360_e9022492-18a7-44e1-9a89-45a4c06c72f1
Mono-Linyah
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
- ndc1116714360011 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACK
- ndc1116714360021 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACK
- ndc1116714360033 BLISTER PACK in 1 CARTON (16714-360-03) / 1 KIT in 1 BLISTER PACK
- ndc1116714360046 BLISTER PACK in 1 CARTON (16714-360-04) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A090523
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"84a20017-344b-4684-a915-c85a55fcbbcb": {
"match": "brand_token",
"title": "MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]",
"spl_version": "9",
"published_date": "2025-03-27"
}
},
"productid": "16714-360_e9022492-18a7-44e1-9a89-45a4c06c72f1",
"productndc": "16714-360",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "090523",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;0.25MG",
"product_no": "001",
"approval_date": "May 23, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Mono-Linyah",
"active_ingred_unit": null,
"application_number": "ANDA090523",
"marketing_category": "ANDA",
"nonproprietary_name": "norgestimate and ethinyl estradiol",
"start_marketing_date": "20120523",
"active_numerator_strength": null
}Access this data programmatically
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