ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-126
Product ID 61314-126_2833a9fe-4416-4012-8d2c-c9d5090fd2e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076583
Listing Expiration 2026-12-31
Marketing Start 2009-11-05

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 61314126
Hyphenated Format 61314-126

Supplemental Identifiers

RxCUI
860107
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 ANDA076583 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (61314-126-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (61314-126-10) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

61314-126-05 1 BOTTLE in 1 CARTON (61314-126-05) / 5 mL in 1 BOTTLE 61314-126-10 1 BOTTLE in 1 CARTON (61314-126-10) / 10 mL in 1 BOTTLE

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": "2833a9fe-4416-4012-8d2c-c9d5090fd2e7", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["79e29a86-1b44-4d95-8d84-5a2e8f23ddcf"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (61314-126-05)  / 5 mL in 1 BOTTLE", "package_ndc": "61314-126-05", "marketing_start_date": "20091105"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (61314-126-10)  / 10 mL in 1 BOTTLE", "package_ndc": "61314-126-10", "marketing_start_date": "20091105"}], "brand_name": "KETOROLAC TROMETHAMINE", "product_id": "61314-126_2833a9fe-4416-4012-8d2c-c9d5090fd2e7", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "61314-126", "generic_name": "ketorolac tromethamine", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOROLAC TROMETHAMINE", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA076583", "marketing_category": "ANDA", "marketing_start_date": "20091105", "listing_expiration_date": "20261231"}