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United States · US · US:71335-9631_4629ba57-842d-45ec-8bf9-a1ed10a0a429
misoprostol
Orange BookUNIISPLATC G02AD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG02AD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11713359631128 TABLET in 1 BOTTLE (71335-9631-1)
- ndc11713359631290 TABLET in 1 BOTTLE (71335-9631-2)
- ndc11713359631330 TABLET in 1 BOTTLE (71335-9631-3)
Annotations
UNII (FDA Substance ID)
0E43V0BB57
MISOPROSTOL
RxCUI 42331
Orange Book
N019268
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": "71335-9631_4629ba57-842d-45ec-8bf9-a1ed10a0a429",
"productndc": "71335-9631",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "019268",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.2MG",
"product_no": "001",
"approval_date": "Dec 27, 1988"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "0.1MG",
"product_no": "003",
"approval_date": "Sep 21, 1990"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MISOPROSTOL",
"proprietary_name": "misoprostol",
"active_ingred_unit": "ug/1",
"application_number": "NDA019268",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "MISOPROSTOL",
"start_marketing_date": "20091227",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02AD06.
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