ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler glenmark pharmaceuticals inc., usa
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketorolac tromethamine 15 mg/mL

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-755
Product ID 68462-755_13abaed4-8500-4f56-ae13-16803092fc78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217789
Listing Expiration 2027-12-31
Marketing Start 2023-10-19

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 68462755
Hyphenated Format 68462-755

Supplemental Identifiers

RxCUI
860092 1665459 1665461
UPC
0368462756010 0368462757024 0368462755259 0368462757253 0368462755013 0368462756256
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
  • 15 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (68462-755-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68462-755-01)
source: ndc

Packages (1)

68462-755-25 25 VIAL, SINGLE-DOSE in 1 CARTON (68462-755-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68462-755-01)

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": "13abaed4-8500-4f56-ae13-16803092fc78", "openfda": {"upc": ["0368462756010", "0368462757024", "0368462755259", "0368462757253", "0368462755013", "0368462756256"], "unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["ce992bee-a9f5-48bd-a00e-513f590d69f2"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (68462-755-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (68462-755-01)", "package_ndc": "68462-755-25", "marketing_start_date": "20231019"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "68462-755_13abaed4-8500-4f56-ae13-16803092fc78", "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": "68462-755", "generic_name": "ketorolac tromethamine", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "15 mg/mL"}], "application_number": "ANDA217789", "marketing_category": "ANDA", "marketing_start_date": "20231019", "listing_expiration_date": "20271231"}