🇺🇸
United States · US · US:65162-438_0426969f-80c3-4157-b42a-ad57d204d011
Diclofenac Sodium and Misoprostol
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651624380330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-03)
- ndc11651624380660 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-06)
- ndc116516243810100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10)
Annotations
UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A203995
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": "65162-438_0426969f-80c3-4157-b42a-ad57d204d011",
"productndc": "65162-438",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "203995",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG;0.2MG",
"product_no": "001",
"approval_date": "Nov 25, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG;0.2MG",
"product_no": "002",
"approval_date": "Nov 25, 2016"
}
],
"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": "ANDA203995",
"marketing_category": "ANDA",
"nonproprietary_name": "Diclofenac Sodium and Misoprostol",
"start_marketing_date": "20161201",
"active_numerator_strength": "75; 200"
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