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United States · US · US:16714-347_bca1e775-2fc3-43df-8c55-e4e7b959f4fb
Philith
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
- ndc1116714347011 BLISTER PACK in 1 PACKET (16714-347-01) / 1 KIT in 1 BLISTER PACK
- ndc1116714347021 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACK
- ndc1116714347033 BLISTER PACK in 1 CARTON (16714-347-03) / 1 KIT in 1 BLISTER PACK
- ndc1116714347046 BLISTER PACK in 1 CARTON (16714-347-04) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A090947
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"77b8d3ef-f3ac-4148-84f0-f6cb327c9f78": {
"match": "brand_token",
"title": "PHILITH (NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS) KIT [NORTHSTAR RX LLC]",
"spl_version": "8",
"published_date": "2025-12-10"
}
},
"productid": "16714-347_bca1e775-2fc3-43df-8c55-e4e7b959f4fb",
"productndc": "16714-347",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "090947",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;0.4MG",
"product_no": "001",
"approval_date": "Dec 22, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Philith",
"active_ingred_unit": null,
"application_number": "ANDA090947",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone and Ethinyl Estradiol Tablets",
"start_marketing_date": "20111222",
"active_numerator_strength": null
}Access this data programmatically
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