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Caldolor

These highlights do not include all the information needed to use CALDOLOR safely and effectively. See full prescribing information for CALDOLOR. CALDOLOR (ibuprofen injection), for intravenous useInitial U.S. Approval: 1974

Approved
Approval ID

1eaa7790-f1a1-4f51-b10a-cbbaf033f684

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 17, 2023

Manufacturers
FDA

Cumberland Pharmaceuticals Inc.

DUNS: 069532880

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66220-284
Application NumberNDA022348
Product Classification
M
Marketing Category
C73594
G
Generic Name
ibuprofen
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2020
FDA Product Classification

INGREDIENTS (5)

ibuprofenActive
Quantity: 800 mg in 200 mL
Code: WK2XYI10QM
Classification: ACTIB
sodium phosphate, dibasic, unspecified formInactive
Code: GR686LBA74
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT

ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66220-287
Application NumberNDA022348
Product Classification
M
Marketing Category
C73594
G
Generic Name
ibuprofen
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2020
FDA Product Classification

INGREDIENTS (5)

ibuprofenActive
Quantity: 800 mg in 8 mL
Code: WK2XYI10QM
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
arginineInactive
Code: 94ZLA3W45F
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT

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Caldolor - FDA Drug Approval Details