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United States · US · US:0591-0398_9d8d5f09-7764-4e55-87c6-d2fead0e6e97
Diclofenac Sodium and Misoprostol
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11059103986060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0398-60)
Annotations
UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A201089
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": "0591-0398_9d8d5f09-7764-4e55-87c6-d2fead0e6e97",
"productndc": "0591-0398",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "201089",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG;0.2MG",
"product_no": "001",
"approval_date": "Jul 9, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;0.2MG",
"product_no": "002",
"approval_date": "Jul 9, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICLOFENAC SODIUM; MISOPROSTOL",
"proprietary_name": "Diclofenac Sodium and Misoprostol",
"active_ingred_unit": "mg/1; ug/1",
"application_number": "ANDA201089",
"marketing_category": "ANDA",
"nonproprietary_name": "Diclofenac Sodium and Misoprostol",
"start_marketing_date": "20121101",
"active_numerator_strength": "75; 200"
}Related drugs
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