🇺🇸
United States · US · US:68001-280_411b49de-cfcc-2b9f-e063-6394a90a06b7
Diclofenac Sodium
Orange BookUNIISPLATC M01AB55
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeM01AB55
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116800128000100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-280-00)
- ndc11680012800660 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-280-06)
- ndc1168001280081000 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-280-08)
Annotations
UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A090066
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": "68001-280_411b49de-cfcc-2b9f-e063-6394a90a06b7",
"productndc": "68001-280",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "090066",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Dec 1, 2010"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Dec 1, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICLOFENAC SODIUM",
"proprietary_name": "Diclofenac Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090066",
"marketing_category": "ANDA",
"nonproprietary_name": "Diclofenac Sodium",
"start_marketing_date": "20151221",
"active_numerator_strength": "50"
}Related drugs
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