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United States · US · US:54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafb
Misoprostol
Orange BookUNIISPLATC G02AD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmPak, Inc.
CountryUS (United States)
ATC codeG02AD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc1154348148001 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLE
- ndc1154348148011 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLE
- ndc1154348148021 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLE
- ndc1154348148031 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLE
- ndc1154348148041 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLE
- ndc1154348148061 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLE
- ndc1154348148081 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLE
- ndc1154348148091 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
0E43V0BB57
MISOPROSTOL
RxCUI 42331
Orange Book
A091667
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": "54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafb",
"productndc": "54348-148",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091667",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.1MG",
"product_no": "001",
"approval_date": "Jul 25, 2012"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.2MG",
"product_no": "002",
"approval_date": "Jul 25, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MISOPROSTOL",
"proprietary_name": "Misoprostol",
"active_ingred_unit": "ug/1",
"application_number": "ANDA091667",
"marketing_category": "ANDA",
"nonproprietary_name": "MISOPROSTOL",
"start_marketing_date": "20190710",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02AD06.
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