NDC 66220-287

Caldolor

Ibuprofen

Caldolor is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Cumberland Pharmaceuticals Inc.. The primary component is Ibuprofen.

Product ID66220-287_3cb7abc4-a0f6-46e7-be99-9ec5d48df958
NDC66220-287
Product TypeHuman Prescription Drug
Proprietary NameCaldolor
Generic NameIbuprofen
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-06-11
Marketing CategoryNDA / NDA
Application NumberNDA022348
Labeler NameCumberland Pharmaceuticals Inc.
Substance NameIBUPROFEN
Active Ingredient Strength800 mg/8mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 66220-287-08

25 VIAL in 1 CARTON (66220-287-08) > 8 mL in 1 VIAL
Marketing Start Date2009-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66220-287-08 [66220028708]

Caldolor INJECTION
Marketing CategoryNDA
Application NumberNDA022348
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-06-11

NDC 66220-287-11 [66220028711]

Caldolor INJECTION
Marketing CategoryNDA
Application NumberNDA022348
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-06

NDC 66220-287-24 [66220028724]

Caldolor INJECTION
Marketing CategoryNDA
Application NumberNDA022348
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-01
Marketing End Date2020-09-03

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/8mL

OpenFDA Data

SPL SET ID:1eaa7790-f1a1-4f51-b10a-cbbaf033f684
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854187
  • 854183
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "Caldolor" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    66220-287CaldolorCaldolor
    66220-284CaldolorCaldolor
    0113-1461basic care childrens ibuprofenIbuprofen
    0113-7619basic care childrens ibuprofenibuprofen
    0113-7660basic care childrens ibuprofenIbuprofen
    0113-7897Basic Care childrens ibuprofenIbuprofen
    0113-0788Basic Care ibuprofenIbuprofen
    0113-7131basic care ibuprofenIbuprofen
    0113-7517basic care ibuprofenIbuprofen
    0113-7604Basic Care IbuprofenIbuprofen
    0121-0917Childrens IbuprofenIbuprofen
    0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
    0113-2461Good Sense Childrens IbuprofenIbuprofen
    0113-0057Good Sense ibuprofenibuprofen
    0113-0074Good Sense ibuprofenIbuprofen
    0113-0166good sense ibuprofenIbuprofen
    0113-0298good sense ibuprofenIbuprofen
    0113-0461Good Sense ibuprofenIbuprofen
    0113-0517Good Sense ibuprofenIbuprofen
    0113-0604good sense ibuprofenIbuprofen
    0113-0647good sense ibuprofenIbuprofen
    0113-0660Good Sense IbuprofenIbuprofen
    0113-0685Good Sense IbuprofenIbuprofen
    0113-0897good sense ibuprofenIbuprofen
    0113-1212Good Sense IbuprofenIbuprofen
    0113-4501good sense ibuprofenibuprofen
    0113-0040Good Sense Infants IbuprofenIbuprofen

    Trademark Results [Caldolor]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CALDOLOR
    CALDOLOR
    77559307 3659228 Live/Registered
    Cumberland Pharmaceuticals Inc.
    2008-08-29
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