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United States · US · US:59390-149_0561ff06-43b4-493e-93f7-b778fc829036
Diclofenac
Orange BookUNIISPLATC M01AB55
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAltaire Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01AB55
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159390149021 BOTTLE, DROPPER in 1 CARTON (59390-149-02) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1159390149051 BOTTLE, DROPPER in 1 CARTON (59390-149-05) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A203383
AT
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": "OPHTHALMIC",
"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": "59390-149_0561ff06-43b4-493e-93f7-b778fc829036",
"productndc": "59390-149",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "203383",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Nov 16, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICLOFENAC SODIUM",
"proprietary_name": "Diclofenac",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203383",
"marketing_category": "ANDA",
"nonproprietary_name": "Diclofenac Sodium",
"start_marketing_date": "20151116",
"active_numerator_strength": "1"
}Related drugs
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