🇺🇸
United States · US · US:16714-441_bc5880ea-5359-4f40-a2e5-7af0b1131a9c
SHAROBEL
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
- ndc1116714441011 BLISTER PACK in 1 PACKET (16714-441-01) / 1 KIT in 1 BLISTER PACK
- ndc1116714441021 BLISTER PACK in 1 CARTON (16714-441-02) / 1 KIT in 1 BLISTER PACK
- ndc1116714441033 BLISTER PACK in 1 CARTON (16714-441-03) / 1 KIT in 1 BLISTER PACK
- ndc1116714441046 BLISTER PACK in 1 CARTON (16714-441-04) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A200961
AB2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"a96f5194-ad2a-4783-a9a9-22a288caff25": {
"match": "brand_token",
"title": "SHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]",
"spl_version": "9",
"published_date": "2025-12-10"
}
},
"productid": "16714-441_bc5880ea-5359-4f40-a2e5-7af0b1131a9c",
"productndc": "16714-441",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "200961",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "0.35MG",
"product_no": "001",
"approval_date": "Sep 13, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "SHAROBEL",
"active_ingred_unit": null,
"application_number": "ANDA200961",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone",
"start_marketing_date": "20130913",
"active_numerator_strength": null
}Access this data programmatically
Query SHAROBEL and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.