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United States · US · US:59651-740_450fc33f-0716-47fe-b810-f10f372ab98a
Rhuzdah
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159651740883 POUCH in 1 CARTON (59651-740-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
- ndc1159651740926 POUCH in 1 CARTON (59651-740-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A207585
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"dea10e78-0e7b-4404-9c3a-ed2447a1788b": {
"match": "brand_token",
"title": "RHUZDAH (NORETHINDRONE AND ETHINYL ESTRADIOL TABLET) KIT [AUROBINDO PHARMA LIMITED]",
"spl_version": "3",
"published_date": "2023-11-24"
}
},
"productid": "59651-740_450fc33f-0716-47fe-b810-f10f372ab98a",
"productndc": "59651-740",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "207585",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.035MG;0.4MG",
"product_no": "001",
"approval_date": "Oct 11, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Rhuzdah",
"active_ingred_unit": null,
"application_number": "ANDA207585",
"marketing_category": "ANDA",
"nonproprietary_name": "norethindrone and ethinyl estradiol tablet",
"start_marketing_date": "20221011",
"active_numerator_strength": null
}Access this data programmatically
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