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 INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 60 mg/2mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-935
Product ID 47335-935_4d86168f-6d0f-4338-8e59-9ad241a9fadb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078737
Listing Expiration 2026-12-31
Marketing Start 2022-12-25

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 47335935
Hyphenated Format 47335-935

Supplemental Identifiers

RxCUI
860092 1665459 1665461
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 ANDA078737 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 60 mg/2mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (47335-935-45) / 1 mL in 1 VIAL, SINGLE-DOSE (47335-935-40)
source: ndc

Packages (1)

47335-935-45 25 VIAL, SINGLE-DOSE in 1 CARTON (47335-935-45) / 1 mL in 1 VIAL, SINGLE-DOSE (47335-935-40)

Ingredients (1)

ketorolac tromethamine (60 mg/2mL)

Linked Drug Pages (1)

ketorolac tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "4d86168f-6d0f-4338-8e59-9ad241a9fadb", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860092", "1665459", "1665461"], "spl_set_id": ["29a92a7c-68d1-489b-ba27-d788b3153795"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (47335-935-45)  / 1 mL in 1 VIAL, SINGLE-DOSE (47335-935-40)", "package_ndc": "47335-935-45", "marketing_start_date": "20221225"}], "brand_name": "ketorolac tromethamine", "product_id": "47335-935_4d86168f-6d0f-4338-8e59-9ad241a9fadb", "dosage_form": "INJECTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "47335-935", "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": "60 mg/2mL"}], "application_number": "ANDA078737", "marketing_category": "ANDA", "marketing_start_date": "20221225", "listing_expiration_date": "20261231"}