ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler caplin steriles limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-145
Product ID 65145-145_f12a602a-98ed-4ceb-bcef-f30bbd8fd7fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217789
Listing Expiration 2026-12-31
Marketing Start 2024-10-04

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 65145145
Hyphenated Format 65145-145

Supplemental Identifiers

RxCUI
860092 1665459 1665461
UPC
0365145147011 0365145146250 0365145146014 0365145145253 0365145147257 0365145145017
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 ANDA217789 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (65145-145-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-145-01)
source: ndc

Packages (1)

65145-145-25 25 VIAL, SINGLE-DOSE in 1 CARTON (65145-145-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-145-01)

Ingredients (1)

ketorolac tromethamine (30 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": "f12a602a-98ed-4ceb-bcef-f30bbd8fd7fa", "openfda": {"upc": ["0365145147011", "0365145146250", "0365145146014", "0365145145253", "0365145147257", "0365145145017"], "unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["588b4804-4ac5-4b96-947e-354029ea4df9"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (65145-145-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (65145-145-01)", "package_ndc": "65145-145-25", "marketing_start_date": "20241004"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "65145-145_f12a602a-98ed-4ceb-bcef-f30bbd8fd7fa", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "65145-145", "generic_name": "ketorolac tromethamine", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "30 mg/mL"}], "application_number": "ANDA217789", "marketing_category": "ANDA", "marketing_start_date": "20241004", "listing_expiration_date": "20261231"}