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United States · US · US:82804-037_85410e16-d164-4666-9539-778e2b4dd138
Misoprostol
Orange BookUNIISPLATC G02AD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG02AD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11828040371010 TABLET in 1 BOTTLE (82804-037-10)
- ndc11828040372020 TABLET in 1 BOTTLE (82804-037-20)
- ndc11828040373030 TABLET in 1 BOTTLE (82804-037-30)
- ndc11828040376060 TABLET in 1 BOTTLE (82804-037-60)
- ndc11828040379090 TABLET in 1 BOTTLE (82804-037-90)
Annotations
UNII (FDA Substance ID)
0E43V0BB57
MISOPROSTOL
RxCUI 42331
Orange Book
A076095
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": "82804-037_85410e16-d164-4666-9539-778e2b4dd138",
"productndc": "82804-037",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076095",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1MG",
"product_no": "001",
"approval_date": "Jul 10, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.2MG",
"product_no": "002",
"approval_date": "Jul 10, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MISOPROSTOL",
"proprietary_name": "Misoprostol",
"active_ingred_unit": "ug/1",
"application_number": "ANDA076095",
"marketing_category": "ANDA",
"nonproprietary_name": "Misoprostol",
"start_marketing_date": "20220411",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02AD06.
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