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United States · US · US:80425-0273_12141491-25f0-fbc5-e063-6394a90a1f23
DICLOENAC SODIUM and MISOPROSTOL
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11804250273160 TABLET in 1 BOTTLE (80425-0273-1)
Annotations
UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A204355
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QTG126297Q",
"rxcui": "203214",
"inchikey": "KPHWPUGNDIVLNH-UHFFFAOYSA-M",
"display_name": "DICLOFENAC SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f4d8c198-63e1-3109-e053-2995a90acad9": {
"match": "brand_token",
"title": "DICLOENAC SODIUM AND MISOPROSTOL DR (DICLOENAC SODIUM AND MISOPROSTOL) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]",
"spl_version": "2",
"published_date": "2024-02-27"
}
},
"productid": "80425-0273_12141491-25f0-fbc5-e063-6394a90a1f23",
"productndc": "80425-0273",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204355",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG;0.2MG",
"product_no": "001",
"approval_date": "Jul 15, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;0.2MG",
"product_no": "002",
"approval_date": "Jul 15, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICLOFENAC SODIUM; MISOPROSTOL",
"proprietary_name": "DICLOENAC SODIUM and MISOPROSTOL",
"active_ingred_unit": "mg/1; ug/1",
"application_number": "ANDA204355",
"marketing_category": "ANDA",
"nonproprietary_name": "DICLOENAC SODIUM and MISOPROSTOL",
"start_marketing_date": "20230216",
"active_numerator_strength": "75; 200"
}Related drugs
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