ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-220
Product ID 47335-220_26b840cb-75b8-41f1-bcbb-287a0b2eca52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090017
Listing Expiration 2026-12-31
Marketing Start 2018-03-13

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 47335220
Hyphenated Format 47335-220

Supplemental Identifiers

RxCUI
860107
UPC
0347335219906 0347335220902 0347335221909
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 ANDA090017 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (47335-220-90) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

47335-220-90 1 BOTTLE, DROPPER in 1 CARTON (47335-220-90) / 5 mL in 1 BOTTLE, DROPPER

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": "26b840cb-75b8-41f1-bcbb-287a0b2eca52", "openfda": {"upc": ["0347335219906", "0347335220902", "0347335221909"], "unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["2c76b8f9-5385-4c98-aebb-bdca8613d24b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (47335-220-90)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "47335-220-90", "marketing_start_date": "20180313"}], "brand_name": "Ketorolac Tromethamine", "product_id": "47335-220_26b840cb-75b8-41f1-bcbb-287a0b2eca52", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "47335-220", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA090017", "marketing_category": "ANDA", "marketing_start_date": "20180313", "listing_expiration_date": "20261231"}