ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: onesource specialty pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler onesource specialty pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketorolac tromethamine 15 mg/mL

Manufacturer
Onesource Specialty Pharma Limited

Identifiers & Regulatory

Product NDC 83270-157
Product ID 83270-157_45964863-b614-400a-e063-6294a90ac151
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201155
Listing Expiration 2026-12-31
Marketing Start 2023-09-30

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 83270157
Hyphenated Format 83270-157

Supplemental Identifiers

RxCUI
860113 860114 860115
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 ketorolac tromethamine (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number ANDA201155 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (83270-157-01) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

83270-157-01 1 SYRINGE, GLASS in 1 CARTON (83270-157-01) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

ketorolac tromethamine (15 mg/mL)

Linked Drug Pages (1)

KETOROLAC TROMETHAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "45964863-b614-400a-e063-6294a90ac151", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860113", "860114", "860115"], "spl_set_id": ["4596483b-990b-eaa4-e063-6394a90ac08f"], "manufacturer_name": ["Onesource Specialty Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (83270-157-01)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "83270-157-01", "marketing_start_date": "20230930"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "83270-157_45964863-b614-400a-e063-6294a90ac151", "dosage_form": "INJECTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83270-157", "generic_name": "KETOROLAC TROMETHAMINE", "labeler_name": "Onesource Specialty Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "15 mg/mL"}], "application_number": "ANDA201155", "marketing_category": "ANDA", "marketing_start_date": "20230930", "listing_expiration_date": "20261231"}