🇺🇸
United States · US · US:50419-423_ab3e1924-b102-48c1-8188-a089524e9dd0
Mirena
Orange BookUNIISPLATC G03AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150419423011 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01)
- ndc1150419423081 INTRAUTERINE DEVICE in 1 CARTON (50419-423-08)
Annotations
UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
N021225
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5W7SIA7YZW",
"rxcui": "6373",
"inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N",
"display_name": "LEVONORGESTREL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAUTERINE",
"spl_meta": {
"dcbd6aa2-b3fa-479a-a676-56ea742962fc": {
"match": "brand_token",
"title": "MIRENA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "20",
"published_date": "2025-11-17"
}
},
"productid": "50419-423_ab3e1924-b102-48c1-8188-a089524e9dd0",
"productndc": "50419-423",
"dosage_form": "INTRAUTERINE DEVICE",
"orange_book": {
"appl_no": "021225",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "52MG",
"product_no": "001",
"approval_date": "Dec 6, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVONORGESTREL",
"proprietary_name": "Mirena",
"active_ingred_unit": "mg/1",
"application_number": "NDA021225",
"marketing_category": "NDA",
"nonproprietary_name": "Levonorgestrel",
"start_marketing_date": "20091001",
"active_numerator_strength": "52"
}Related drugs
Other records sharing ATC code G03AD01.
- 🇺🇸After BangerAurohealth LLC
- 🇺🇸AfteraFoundation Consumer Healthcare LLC
- 🇺🇸AfterPillSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880
- 🇺🇸AfterPlanSUN PHARMACEUTICAL INDUSTRIES, INC.
- 🇺🇸AMAZON BASIC CARE LEVONORGESTRELAmazon.com Services LLC
- 🇺🇸Athentia NextAurohealth LLC
- CABACKUP PLAN ONESTEPAPOTEX INC
- GBBenilexa One Handed 20micrograms/24hours intrauterine delivery systemGedeon Richter (UK) Ltd
Access this data programmatically
Query Mirena 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.