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United States · US · US:16714-370_1f26d981-43da-4b0e-bee1-7d195254fb77
Wera
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
- ndc1116714370011 BLISTER PACK in 1 PACKET (16714-370-01) / 1 KIT in 1 BLISTER PACK
- ndc1116714370021 BLISTER PACK in 1 CARTON (16714-370-02) / 1 KIT in 1 BLISTER PACK
- ndc1116714370033 BLISTER PACK in 1 CARTON (16714-370-03) / 1 KIT in 1 BLISTER PACK
- ndc1116714370046 BLISTER PACK in 1 CARTON (16714-370-04) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A091204
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"638e4f36-1a27-4220-8ec9-3fa9d9b36c11": {
"match": "brand_token",
"title": "WERA ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [NORTHSTAR RX LLC]",
"spl_version": "14",
"published_date": "2026-04-17"
}
},
"productid": "16714-370_1f26d981-43da-4b0e-bee1-7d195254fb77",
"productndc": "16714-370",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "091204",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;0.5MG",
"product_no": "001",
"approval_date": "Mar 27, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Wera",
"active_ingred_unit": null,
"application_number": "ANDA091204",
"marketing_category": "ANDA",
"nonproprietary_name": "norethindrone and ethinyl estradiol",
"start_marketing_date": "20120327",
"active_numerator_strength": null
}Access this data programmatically
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