🇺🇸
United States · US · US:71335-2441_09aef351-9355-4eee-afc9-4c80b5ebf39f
Diclofenac Sodium Misoprostol
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11713352441120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-1)
- ndc11713352441214 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-2)
- ndc11713352441360 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-3)
- ndc11713352441430 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-4)
- ndc11713352441510 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-5)
Annotations
UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A205143
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": "71335-2441_09aef351-9355-4eee-afc9-4c80b5ebf39f",
"productndc": "71335-2441",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "205143",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG;0.2MG",
"product_no": "001",
"approval_date": "Feb 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;0.2MG",
"product_no": "002",
"approval_date": "Feb 19, 2020"
}
],
"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": "ANDA205143",
"marketing_category": "ANDA",
"nonproprietary_name": "diclofenac sodium and misoprostol",
"start_marketing_date": "20210715",
"active_numerator_strength": "75; 200"
}Related drugs
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