NDC 0023-2181

Acular

Ketorolac Tromethamine

Acular 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: 0023-2181_2df33f5e-153b-43fe-b56f-300599573549
• NDC: 0023-2181
• Product Type: Human Prescription Drug
• Proprietary Name: Acular
• Generic Name: Ketorolac Tromethamine
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1992-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA019700
• 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: 2020-12-31

Packaging

NDC 0023-2181-05

1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 1992-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-2181-05 [00023218105]

Acular SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019700
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1992-12-01

NDC 0023-2181-03 [00023218103]

Acular SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019700
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-12-01
• Marketing End Date: 2010-11-10

NDC 0023-2181-10 [00023218110]

Acular SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA019700
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1992-12-01
• Marketing End Date: 2011-04-29

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	5 mg/mL

OpenFDA Data

• SPL SET ID: c94644d3-7b64-4f3d-a0c7-12c77466a0fc
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 860109
  • 860107

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

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

NDC	Brand Name	Generic Name
0023-2181	Acular	Ketorolac Tromethamine
21695-463	ACULAR	ACULAR
0023-9277	ACULAR LS	Ketorolac Tromethamine
0023-3507	ACUVAIL	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