NDC 0338-0076

KETOROLAC TROMETHAMINE

Ketorolac Tromethamine

KETOROLAC TROMETHAMINE is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Ketorolac Tromethamine.

• Product ID: 0338-0076_0072f42c-3a03-4f49-86ba-399cc73f608e
• NDC: 0338-0076
• 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: 2018-11-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209900
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 15 mg/2mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0338-0076-10

10 VIAL in 1 CARTON (0338-0076-10) > 2 mL in 1 VIAL

• Marketing Start Date: 2018-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-0076-10 [00338007610]

KETOROLAC TROMETHAMINE INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA209900
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-30

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	15 mg/2mL

OpenFDA Data

• SPL SET ID: 4b58836d-9d58-4539-9691-9e11c505ef2a
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 1665461
  • 1665459
  • 860092

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"

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