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United States · US · US:42571-254_35016de6-7e52-0209-e063-6394a90ade8e
MISOPROSTOL
Orange BookUNIISPLATC G02AD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeG02AD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114257125401100 TABLET in 1 BOTTLE (42571-254-01)
- ndc11425712546060 TABLET in 1 BOTTLE (42571-254-60)
Annotations
UNII (FDA Substance ID)
0E43V0BB57
MISOPROSTOL
RxCUI 42331
Orange Book
A216872
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0E43V0BB57",
"rxcui": "42331",
"inchikey": "OJLOPKGSLYJEMD-URPKTTJQSA-N",
"display_name": "MISOPROSTOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c4fe14fb-0a43-4c31-9cd6-29eb0d156705": {
"match": "brand_token",
"title": "MISOPROSTOL TABLET [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "15",
"published_date": "2026-05-25"
}
},
"productid": "42571-254_35016de6-7e52-0209-e063-6394a90ade8e",
"productndc": "42571-254",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216872",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1MG",
"product_no": "001",
"approval_date": "Oct 17, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2MG",
"product_no": "002",
"approval_date": "Oct 17, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MISOPROSTOL",
"proprietary_name": "MISOPROSTOL",
"active_ingred_unit": "ug/1",
"application_number": "ANDA216872",
"marketing_category": "ANDA",
"nonproprietary_name": "Misoprostol",
"start_marketing_date": "20230101",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02AD06.
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