NDC 70529-119

Acunivive 15

Ketorolac Tromethamine

Acunivive 15 is a Intramuscular; Intravenous 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: 70529-119_6ee25e1b-3d08-4244-af41-124854f9e6db
• NDC: 70529-119
• Product Type: Human Prescription Drug
• Proprietary Name: Acunivive 15
• Generic Name: Ketorolac Tromethamine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2019-02-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204216
• Labeler Name: IT3 Medical LLC
• Substance Name: KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 15 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 70529-119-15

1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-119-15) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70529-119-15 [70529011915]

Acunivive 15 INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204216
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-01

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	15 mg/mL

OpenFDA Data

• SPL SET ID: 23bae374-5097-4aee-8d98-3995d299e84d
• Manufacturer:
  • IT3 Medical LLC
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 860092

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 "Acunivive 15" or generic name "Ketorolac Tromethamine"

NDC	Brand Name	Generic Name
70529-119	Acunivive 15	Acunivive 15
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