ketorolac tromethamine

Generic: ketorolac tromethamine

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

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-134
Product ID 68083-134_76e27d80-58bb-4ed8-ab33-4b1edd53ef20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2026-12-31
Marketing Start 2016-12-01

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 68083134
Hyphenated Format 68083-134

Supplemental Identifiers

RxCUI
860092 1665459 1665461
UPC
0368083132101 0368083133108 0368083134105
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 ANDA204216 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-134-10) / 2 mL in 1 VIAL (68083-134-01)
source: ndc

Packages (1)

68083-134-10 10 VIAL in 1 CARTON (68083-134-10) / 2 mL in 1 VIAL (68083-134-01)

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"], "spl_id": "76e27d80-58bb-4ed8-ab33-4b1edd53ef20", "openfda": {"upc": ["0368083132101", "0368083133108", "0368083134105"], "unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["5abd4389-4fb2-408b-a27e-cf64b6a921f1"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-134-10)  / 2 mL in 1 VIAL (68083-134-01)", "package_ndc": "68083-134-10", "marketing_start_date": "20161201"}], "brand_name": "ketorolac tromethamine", "product_id": "68083-134_76e27d80-58bb-4ed8-ab33-4b1edd53ef20", "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": "68083-134", "generic_name": "ketorolac tromethamine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ketorolac tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "30 mg/mL"}], "application_number": "ANDA204216", "marketing_category": "ANDA", "marketing_start_date": "20161201", "listing_expiration_date": "20261231"}