NDC 0517-0801

Ketorolac Tromethamine

Ketorolac Tromethamine

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

• Product ID: 0517-0801_75dc1361-b8f8-44ac-980d-47c08d7307cf
• NDC: 0517-0801
• Product Type: Human Prescription Drug
• Proprietary Name: Ketorolac Tromethamine
• Generic Name: Ketorolac Tromethamine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2008-05-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078145
• Labeler Name: American Regent, Inc.
• Substance Name: KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 30 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0517-0801-25

25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0801-25) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2008-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-0801-10 [00517080110]

Ketorolac Tromethamine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078145
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-05-30
• Marketing End Date: 2010-05-31

NDC 0517-0801-25 [00517080125]

Ketorolac Tromethamine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078145
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-05-30
• Marketing End Date: 2010-05-31

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	30 mg/mL

OpenFDA Data

• SPL SET ID: bb3cb6eb-5f5e-4389-81df-2095198c0565
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 1665461
  • 1665459
  • 860092
• UPC Code:
  • 0305170902100
  • 0305170801106
  • 0305170601256
  • 0305170601102
  • 0305170801250
  • 0305170902254

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Cyclooxygenase Inhibitor [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

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

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