NDC 0409-2287

Ketorolac Tromethamine

Ketorolac Tromethamine

Ketorolac Tromethamine is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Ketorolac Tromethamine.

Product ID0409-2287_0b339947-788f-4e38-b6d9-b74a10cc6b89
NDC0409-2287
Product TypeHuman Prescription Drug
Proprietary NameKetorolac Tromethamine
Generic NameKetorolac Tromethamine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2005-04-28
Marketing CategoryANDA / ANDA
Application NumberANDA074993
Labeler NameHospira, Inc.
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength30 mg/mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0409-2287-31

10 CARTRIDGE in 1 CARTON (0409-2287-31) > 1 mL in 1 CARTRIDGE (0409-2287-03)
Marketing Start Date2005-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2287-04 [00409228704]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-05-03

NDC 0409-2287-23 [00409228723]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-09-13
Marketing End Date2018-10-01

NDC 0409-2287-03 [00409228703]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-05-03

NDC 0409-2287-21 [00409228721]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-08-14
Marketing End Date2012-04-01

NDC 0409-2287-22 [00409228722]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-08-14
Marketing End Date2011-10-01

NDC 0409-2287-31 [00409228731]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-04-28

NDC 0409-2287-20 [00409228720]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-02-24
Marketing End Date2018-10-01

NDC 0409-2287-61 [00409228761]

Ketorolac Tromethamine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074993
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-23

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE30 mg/mL

OpenFDA Data

SPL SET ID:a036819d-d0d8-4d95-93c9-d362d943ec2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665679
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Ketorolac Tromethamine" or generic name "Ketorolac Tromethamine"

    NDCBrand NameGeneric Name
    0093-0314Ketorolac TromethamineKetorolac Tromethamine
    0338-0069KETOROLAC TROMETHAMINEketorolac tromethamine
    0338-0072KETOROLAC TROMETHAMINEketorolac tromethamine
    0338-0076KETOROLAC TROMETHAMINEketorolac tromethamine
    0378-1134Ketorolac TromethamineKetorolac Tromethamine
    0409-3796Ketorolac TromethamineKetorolac Tromethamine
    0409-3793Ketorolac TromethamineKetorolac Tromethamine
    0409-3795Ketorolac TromethamineKetorolac Tromethamine
    68071-1787Ketorolac TromethamineKetorolac Tromethamine
    68071-1785Ketorolac TromethamineKetorolac Tromethamine
    68083-132ketorolac tromethamineketorolac tromethamine
    68083-104Ketorolac TromethamineKetorolac Tromethamine
    68083-134ketorolac tromethamineketorolac tromethamine
    68083-103Ketorolac TromethamineKetorolac Tromethamine
    68071-4811Ketorolac TromethamineKetorolac Tromethamine
    68083-133ketorolac tromethamineketorolac tromethamine
    68151-0098Ketorolac TromethamineKetorolac Tromethamine
    68387-440Ketorolac TromethamineKetorolac Tromethamine
    0517-0902Ketorolac TromethamineKetorolac Tromethamine
    0517-0801Ketorolac TromethamineKetorolac Tromethamine
    68788-9321Ketorolac TromethamineKetorolac Tromethamine
    0517-0601Ketorolac TromethamineKetorolac Tromethamine
    68788-7384Ketorolac TromethamineKetorolac Tromethamine
    68788-9205Ketorolac TromethamineKetorolac Tromethamine
    69543-386Ketorolac TromethamineKetorolac Tromethamine
    69543-407Ketorolac TromethamineKetorolac Tromethamine
    0548-9021Ketorolac TromethamineKetorolac Tromethamine
    69543-388Ketorolac TromethamineKetorolac Tromethamine
    69543-405Ketorolac TromethamineKetorolac Tromethamine
    70518-0048Ketorolac TromethamineKetorolac Tromethamine
    70518-1091Ketorolac TromethamineKetorolac Tromethamine
    70518-1165Ketorolac TromethamineKetorolac Tromethamine
    70518-1159Ketorolac TromethamineKetorolac Tromethamine
    70518-1669Ketorolac TromethamineKetorolac Tromethamine
    70518-1239Ketorolac TromethamineKetorolac Tromethamine
    70518-1074Ketorolac TromethamineKetorolac Tromethamine
    70518-1340Ketorolac TromethamineKetorolac Tromethamine
    70518-1889Ketorolac TromethamineKetorolac Tromethamine
    70860-700Ketorolac TromethamineKetorolac Tromethamine
    70860-701Ketorolac TromethamineKetorolac Tromethamine
    70934-029Ketorolac TromethamineKetorolac Tromethamine
    71205-116Ketorolac TromethamineKetorolac Tromethamine
    71872-7131Ketorolac TromethamineKetorolac Tromethamine
    71872-7022Ketorolac TromethamineKetorolac Tromethamine
    71872-7118Ketorolac TromethamineKetorolac Tromethamine
    71872-7119Ketorolac TromethamineKetorolac Tromethamine
    71872-7132Ketorolac TromethamineKetorolac Tromethamine
    72266-118ketorolac tromethamineketorolac tromethamine
    72266-119ketorolac tromethamineketorolac tromethamine
    76045-104Ketorolac TromethamineKetorolac Tromethamine

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