NDC 66220-284

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 ID66220-284_3cb7abc4-a0f6-46e7-be99-9ec5d48df958
NDC66220-284
Product TypeHuman Prescription Drug
Proprietary NameCaldolor
Generic NameIbuprofen
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-01
Marketing CategoryNDA / NDA
Application NumberNDA022348
Labeler NameCumberland Pharmaceuticals Inc.
Substance NameIBUPROFEN
Active Ingredient Strength800 mg/200mL
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 66220-284-22

20 BAG in 1 CASE (66220-284-22) > 200 mL in 1 BAG (66220-284-11)
Marketing Start Date2020-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66220-284-11 [66220028411]

Caldolor INJECTION
Marketing CategoryNDA
Application NumberNDA022348
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-01

NDC 66220-284-22 [66220028422]

Caldolor INJECTION
Marketing CategoryNDA
Application NumberNDA022348
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-01

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/200mL

Pharmacological Class

  • Cyclooxygenase Inhibitors [MoA]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • 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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.