NDC 70529-121

Acunivive 60

Ketorolac Tromethamine

Acunivive 60 is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by It3 Medical Llc. The primary component is Ketorolac Tromethamine.

• Product ID: 70529-121_184c81ef-dd69-48d6-bd4f-88d4b1279ad1
• NDC: 70529-121
• Product Type: Human Prescription Drug
• Proprietary Name: Acunivive 60
• Generic Name: Ketorolac Tromethamine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2017-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204216
• Labeler Name: IT3 Medical LLC
• Substance Name: KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 30 mg/mL
• Pharm Classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 70529-121-60

1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-121-60) > 2 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70529-121-60 [70529012160]

Acunivive 60 INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204216
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-01

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	30 mg/mL

OpenFDA Data

• SPL SET ID: a22bd9ab-261f-4d3b-89c6-ad3b10d9a826
• Manufacturer:
  • IT3 Medical LLC
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 1665459

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 "Acunivive 60" or generic name "Ketorolac Tromethamine"

NDC	Brand Name	Generic Name
70529-121	Acunivive 60	Acunivive 60
0023-2181	Acular	Ketorolac Tromethamine
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