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United States · US · US:72789-300_4bae2c7c-35bd-ec85-e063-6394a90a5412
Misoprostol
Orange BookUNIISPLATC G02AD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02AD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1172789300044 TABLET in 1 BOTTLE, PLASTIC (72789-300-04)
- ndc1172789300088 TABLET in 1 BOTTLE, PLASTIC (72789-300-08)
- ndc11727893002020 TABLET in 1 BOTTLE, PLASTIC (72789-300-20)
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": "72789-300_4bae2c7c-35bd-ec85-e063-6394a90a5412",
"productndc": "72789-300",
"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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