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United States · US · US:70954-444_f271c446-37dd-4a1f-8664-c8ccea4ab1ce
Misoprostol
Orange BookUNIISPLATC G02AD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02AD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11709544441060 TABLET in 1 BOTTLE (70954-444-10)
- ndc117095444420100 TABLET in 1 BOTTLE (70954-444-20)
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": "70954-444_f271c446-37dd-4a1f-8664-c8ccea4ab1ce",
"productndc": "70954-444",
"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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