ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8549
Product ID 68788-8549_1436683c-28de-4c28-94f2-d062d1918b2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203410
Listing Expiration 2026-12-31
Marketing Start 2023-11-15

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 687888549
Hyphenated Format 68788-8549

Supplemental Identifiers

RxCUI
860107
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 ANDA203410 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (68788-8549-5)
source: ndc

Packages (1)

68788-8549-5 5 mL in 1 BOTTLE (68788-8549-5)

Ingredients (1)

ketorolac tromethamine (5 mg/mL)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1436683c-28de-4c28-94f2-d062d1918b2a", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["92546f61-bbd8-430a-ac92-89dfbe8e2f29"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (68788-8549-5)", "package_ndc": "68788-8549-5", "marketing_start_date": "20231115"}], "brand_name": "Ketorolac Tromethamine", "product_id": "68788-8549_1436683c-28de-4c28-94f2-d062d1918b2a", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-8549", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA203410", "marketing_category": "ANDA", "marketing_start_date": "20231115", "listing_expiration_date": "20261231"}