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United States · US · US:68462-849_920756d5-a617-404c-968d-ccf58740fa1e
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462849293 CARTON in 1 BOX (68462-849-29) / 1 BLISTER PACK in 1 CARTON (68462-849-84) / 1 KIT in 1 BLISTER PACK * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-821-40) * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-822-40)
Annotations
Orange Book
A213418
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
"match": "brand_token",
"title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
"spl_version": "7",
"published_date": "2026-03-27"
}
},
"productid": "68462-849_920756d5-a617-404c-968d-ccf58740fa1e",
"productndc": "68462-849",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "213418",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.02MG;1MG",
"product_no": "001",
"approval_date": "Jul 27, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
"active_ingred_unit": null,
"application_number": "ANDA213418",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
"start_marketing_date": "20220727",
"active_numerator_strength": null
}Access this data programmatically
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