🇺🇸
United States · US · US:42571-133_3afc5367-562f-b4a0-e063-6294a90a2560
Diclofenac Sodium/Misoprostol
Orange BookUNIISPLATC D11AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeD11AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11425711332960 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK
- ndc11425711333030 TABLET in 1 BOTTLE (42571-133-30)
- ndc11425711336060 TABLET in 1 BOTTLE (42571-133-60)
- ndc11425711339090 TABLET in 1 BOTTLE (42571-133-90)
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": "42571-133_3afc5367-562f-b4a0-e063-6294a90a2560",
"productndc": "42571-133",
"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": "50; 200"
}Related drugs
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