NDC 63187-777

Ketorolac Tromethamine

Ketorolac Tromethamine

Ketorolac Tromethamine is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Ketorolac Tromethamine.

• Product ID: 63187-777_94c12e6e-b723-44eb-865b-869f9a58d91b
• NDC: 63187-777
• Product Type: Human Prescription Drug
• Proprietary Name: Ketorolac Tromethamine
• Generic Name: Ketorolac Tromethamine
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2009-12-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076109
• Labeler Name: Proficient Rx LP
• Substance Name: KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 5 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 63187-777-05

1 BOTTLE, DROPPER in 1 CARTON (63187-777-05) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2016-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63187-777-05 [63187077705]

Ketorolac Tromethamine SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA076109
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-11-01

NDC 63187-777-10 [63187077710]

Ketorolac Tromethamine SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA076109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-11-01

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	5 mg/mL

OpenFDA Data

• SPL SET ID: 2f27e304-7a96-47b6-8ef1-8a649c25abcf
• Manufacturer:
  • Proficient Rx LP
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 860107

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