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United States · US · US:72789-435_32475b1f-ec92-8f6e-e063-6294a90aad75
norgestimate and ethinyl estradiol
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172789435791 BLISTER PACK in 1 POUCH (72789-435-79) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A200541
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"35c6507c-555a-45ed-aaf6-8695831de71a": {
"match": "brand_token",
"title": "NORGESTIMATE AND ETHINYL ESTRADIOL KIT [A-S MEDICATION SOLUTIONS]",
"spl_version": "12",
"published_date": "2026-04-01"
}
},
"productid": "72789-435_32475b1f-ec92-8f6e-e063-6294a90aad75",
"productndc": "72789-435",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "200541",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG",
"product_no": "001",
"approval_date": "Jun 25, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "norgestimate and ethinyl estradiol",
"active_ingred_unit": null,
"application_number": "ANDA200541",
"marketing_category": "ANDA",
"nonproprietary_name": "norgestimate and ethinyl estradiol",
"start_marketing_date": "20200108",
"active_numerator_strength": null
}Access this data programmatically
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