NDC 0023-3507

ACUVAIL

Ketorolac Tromethamine

ACUVAIL is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Ketorolac Tromethamine.

• Product ID: 0023-3507_052989cc-49d1-4dc9-9582-6d7c6809cfe0
• NDC: 0023-3507
• Product Type: Human Prescription Drug
• Proprietary Name: ACUVAIL
• Generic Name: Ketorolac Tromethamine
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2009-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA022427
• Labeler Name: Allergan, Inc.
• 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: 2021-12-31

Packaging

NDC 0023-3507-05

5 VIAL, SINGLE-USE in 1 CARTON (0023-3507-05) > .4 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2009-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-3507-31 [00023350731]

ACUVAIL SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA022427
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-01

NDC 0023-3507-05 [00023350705]

ACUVAIL SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA022427
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-01

NDC 0023-3507-30 [00023350730]

ACUVAIL SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA022427
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-08-01
• Marketing End Date: 2020-10-01

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	4.5 mg/mL

OpenFDA Data

• SPL SET ID: 3cea5803-a446-4d2c-9747-f3fb034332c8
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 858366
  • 858364

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0023-3507	ACUVAIL	ketorolac tromethamine
0023-2181	Acular	Ketorolac Tromethamine
0023-9277	ACULAR LS	Ketorolac Tromethamine
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