NDC 66993-193

Ketorolac Tromethamine

Ketorolac Tromethamine

Ketorolac Tromethamine is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Prasco Laboratories. The primary component is Ketorolac Tromethamine.

Product ID66993-193_41ba3a32-8331-43e8-b9a1-4fe5818ae08a
NDC66993-193
Product TypeHuman Prescription Drug
Proprietary NameKetorolac Tromethamine
Generic NameKetorolac Tromethamine
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2020-02-24
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022382
Labeler NamePrasco Laboratories
Substance NameKETOROLAC TROMETHAMINE
Active Ingredient Strength16 mg/1
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 66993-193-95

5 BOTTLE, SPRAY in 1 CARTON (66993-193-95) > 1 BOTTLE, UNIT-DOSE in 1 BOTTLE, SPRAY (66993-193-83) > 8 SPRAY, METERED in 1 BOTTLE, UNIT-DOSE
Marketing Start Date2020-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66993-193-83 [66993019383]

Ketorolac Tromethamine SPRAY, METERED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA022382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-24

NDC 66993-193-95 [66993019395]

Ketorolac Tromethamine SPRAY, METERED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA022382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-24

Drug Details

Active Ingredients

IngredientStrength
KETOROLAC TROMETHAMINE15.75 mg/1

Pharmacological Class

  • Cyclooxygenase Inhibitors [MoA]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.