sprix

Generic: ketorolac tromethamine

Labeler: zyla life sciences us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sprix
Generic Name ketorolac tromethamine
Labeler zyla life sciences us llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

ketorolac tromethamine 15.75 mg/1

Manufacturer
Zyla Life Sciences US LLC

Identifiers & Regulatory

Product NDC 69344-144
Product ID 69344-144_6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022382
Listing Expiration 2026-12-31
Marketing Start 2011-04-26

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitor [epc] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69344144
Hyphenated Format 69344-144

Supplemental Identifiers

RxCUI
1797855 1797857
UNII
4EVE5946BQ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sprix (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number NDA022382 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 15.75 mg/1
source: ndc
Packaging
  • 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)
  • 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)
source: ndc

Packages (2)

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) 69344-144-53 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)

Ingredients (1)

ketorolac tromethamine (15.75 mg/1)

Linked Drug Pages (1)

Sprix ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1797855", "1797857"], "spl_set_id": ["97005a1c-167e-4676-bae7-e49b38c36f9e"], "manufacturer_name": ["Zyla Life Sciences US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "69344-144-43", "marketing_start_date": "20110426"}, {"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (69344-144-53)  / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)", "package_ndc": "69344-144-53", "marketing_start_date": "20220302"}], "brand_name": "Sprix", "product_id": "69344-144_6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0", "dosage_form": "SPRAY, METERED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69344-144", "generic_name": "ketorolac tromethamine", "labeler_name": "Zyla Life Sciences US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sprix", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "15.75 mg/1"}], "application_number": "NDA022382", "marketing_category": "NDA", "marketing_start_date": "20110426", "listing_expiration_date": "20261231"}