NDC 69344-144

Sprix

Ketorolac Tromethamine

Sprix is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Zyla Life Sciences Us Inc.. The primary component is Ketorolac Tromethamine.

• Product ID: 69344-144_1f065de3-53cf-4ca6-ae6d-a5e0742bc081
• NDC: 69344-144
• Product Type: Human Prescription Drug
• Proprietary Name: Sprix
• Generic Name: Ketorolac Tromethamine
• Dosage Form: Spray, Metered
• Route of Administration: NASAL
• Marketing Start Date: 2011-04-26
• Marketing Category: NDA / NDA
• Application Number: NDA022382
• Labeler Name: Zyla Life Sciences US Inc.
• Substance Name: KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 16 mg/1
• 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: 2022-12-31

Packaging

NDC 69344-144-43

5 CARTON in 1 CARTON (69344-144-43) > 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) > 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)

• Marketing Start Date: 2011-04-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69344-144-53 [69344014453]

Sprix SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA022382
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-04-26

NDC 69344-144-43 [69344014443]

Sprix SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA022382
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-04-26

NDC 69344-144-63 [69344014463]

Sprix SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA022382
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-04-26

Drug Details

Active Ingredients

Ingredient	Strength
KETOROLAC TROMETHAMINE	15.75 mg/1

OpenFDA Data

• SPL SET ID: 97005a1c-167e-4676-bae7-e49b38c36f9e
• Manufacturer:
  • Egalet US Inc.
• UNII:
  • 4EVE5946BQ
• RxNorm Concept Unique ID - RxCUI:
  • 1797855
  • 1797857

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 "Sprix" or generic name "Ketorolac Tromethamine"

NDC	Brand Name	Generic Name
69344-144	Sprix	Sprix
76519-1017	Sprix	Sprix
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