ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler a-s medication solutions
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5013
Product ID 50090-5013_32c52dc4-ef09-4c6c-8c8a-1416be139cd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2026-12-31
Marketing Start 2020-01-21

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 500905013
Hyphenated Format 50090-5013

Supplemental Identifiers

RxCUI
1665461
UNII
4EVE5946BQ

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 INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (50090-5013-0) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 1 mL in 1 VIAL, SINGLE-DOSE (50090-5013-1)
source: ndc

Packages (2)

50090-5013-0 25 VIAL, SINGLE-DOSE in 1 CARTON (50090-5013-0) / 1 mL in 1 VIAL, SINGLE-DOSE 50090-5013-1 1 mL in 1 VIAL, SINGLE-DOSE (50090-5013-1)

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": "32c52dc4-ef09-4c6c-8c8a-1416be139cd4", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665461"], "spl_set_id": ["1ed28531-35a0-488f-9699-0d67d1a79ec4"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (50090-5013-0)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50090-5013-0", "marketing_start_date": "20200416"}, {"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (50090-5013-1)", "package_ndc": "50090-5013-1", "marketing_start_date": "20200416"}], "brand_name": "Ketorolac Tromethamine", "product_id": "50090-5013_32c52dc4-ef09-4c6c-8c8a-1416be139cd4", "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": "50090-5013", "generic_name": "ketorolac tromethamine", "labeler_name": "A-S Medication Solutions", "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": "20200121", "listing_expiration_date": "20261231"}