ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketorolac tromethamine 15 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0069
Product ID 0338-0069_2da4dd8a-1b18-481d-b733-9c031d9ea7e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209900
Listing Expiration 2026-12-31
Marketing Start 2018-11-30

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 03380069
Hyphenated Format 0338-0069

Supplemental Identifiers

RxCUI
860092 1665459 1665461
UPC
0303380072255 0303380069101
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 ANDA209900 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0338-0069-10) / 1 mL in 1 VIAL
source: ndc

Packages (1)

0338-0069-10 10 VIAL in 1 CARTON (0338-0069-10) / 1 mL in 1 VIAL

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": "2da4dd8a-1b18-481d-b733-9c031d9ea7e3", "openfda": {"upc": ["0303380072255", "0303380069101"], "unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["4b58836d-9d58-4539-9691-9e11c505ef2a"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0338-0069-10)  / 1 mL in 1 VIAL", "package_ndc": "0338-0069-10", "marketing_start_date": "20181130"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "0338-0069_2da4dd8a-1b18-481d-b733-9c031d9ea7e3", "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": "0338-0069", "generic_name": "ketorolac tromethamine", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "15 mg/mL"}], "application_number": "ANDA209900", "marketing_category": "ANDA", "marketing_start_date": "20181130", "listing_expiration_date": "20261231"}