🇺🇸
United States · US · US:63187-994_f65ac1f3-6065-44e4-ae2b-da5e52c81157
Diclofenac Sodium
Orange BookUNIISPLATC M01AB55
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM01AB55
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11631879941515 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-15)
- ndc11631879942020 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-20)
- ndc11631879943030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-30)
- ndc11631879946060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-60)
- ndc11631879949090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-90)
Annotations
UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A075492
AB
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": "63187-994_f65ac1f3-6065-44e4-ae2b-da5e52c81157",
"productndc": "63187-994",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075492",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Feb 11, 2000"
}
],
"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": "ANDA075492",
"marketing_category": "ANDA",
"nonproprietary_name": "Diclofenac Sodium",
"start_marketing_date": "20000228",
"active_numerator_strength": "100"
}Related drugs
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