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United States · US · US:66220-287_42d97e40-3617-496a-96e7-d95cbd530bc6
Caldolor
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCumberland Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11662202870825 VIAL in 1 CARTON (66220-287-08) / 8 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N022348
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WK2XYI10QM",
"rxcui": "5640",
"inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
"display_name": "IBUPROFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"1eaa7790-f1a1-4f51-b10a-cbbaf033f684": {
"match": "brand_token",
"title": "CALDOLOR (IBUPROFEN) INJECTION [CUMBERLAND PHARMACEUTICALS INC.]",
"spl_version": "16",
"published_date": "2025-02-17"
}
},
"productid": "66220-287_42d97e40-3617-496a-96e7-d95cbd530bc6",
"productndc": "66220-287",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "022348",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "400MG/4ML (100MG/ML)",
"product_no": "001",
"approval_date": "Jun 11, 2009"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "800MG/8ML (100MG/ML)",
"product_no": "002",
"approval_date": "Jun 11, 2009"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "800MG/200ML (4MG/ML)",
"product_no": "003",
"approval_date": "Jan 25, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Caldolor",
"active_ingred_unit": "mg/8mL",
"application_number": "NDA022348",
"marketing_category": "NDA",
"nonproprietary_name": "ibuprofen",
"start_marketing_date": "20090611",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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