🇺🇸
United States · US · US:85766-192_4dc17730-088f-451b-e063-6294a90a032c
Diclofenac Sodium/Misoprostol
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc1185766192077 TABLET in 1 BOTTLE (85766-192-07)
- ndc11857661921010 TABLET in 1 BOTTLE (85766-192-10)
- ndc11857661921414 TABLET in 1 BOTTLE (85766-192-14)
- ndc11857661921515 TABLET in 1 BOTTLE (85766-192-15)
- ndc11857661922020 TABLET in 1 BOTTLE (85766-192-20)
- ndc11857661923030 TABLET in 1 BOTTLE (85766-192-30)
- ndc11857661926060 TABLET in 1 BOTTLE (85766-192-60)
- ndc11857661929090 TABLET in 1 BOTTLE (85766-192-90)
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": {
"86461915-9bc1-43d4-8d92-6eef3e56bd90": {
"match": "brand_token",
"title": "DICLOFENAC POTASSIUM TABLET, COATED [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-06-01"
}
},
"productid": "85766-192_4dc17730-088f-451b-e063-6294a90a032c",
"productndc": "85766-192",
"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": "Diclofenac Sodium/Misoprostol",
"active_ingred_unit": "mg/1; ug/1",
"application_number": "ANDA204355",
"marketing_category": "ANDA",
"nonproprietary_name": "Diclofenac Sodium/Misoprostol",
"start_marketing_date": "20210901",
"active_numerator_strength": "75; 200"
}Related drugs
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