ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-020
Product ID 82868-020_47fc7966-9df4-e94b-e063-6394a90a3461
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215788
Listing Expiration 2027-12-31
Marketing Start 2023-10-19

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 82868020
Hyphenated Format 82868-020

Supplemental Identifiers

RxCUI
834022
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 ANDA215788 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-20)
source: ndc

Packages (2)

82868-020-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-15) 82868-020-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-20)

Ingredients (1)

ketorolac tromethamine (10 mg/1)

Linked Drug Pages (1)

Ketorolac Tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47fc7966-9df4-e94b-e063-6394a90a3461", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["08674066-7d4b-936d-e063-6394a90abbd7"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-15)", "package_ndc": "82868-020-15", "marketing_start_date": "20231019"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-20)", "package_ndc": "82868-020-20", "marketing_start_date": "20231114"}], "brand_name": "Ketorolac Tromethamine", "product_id": "82868-020_47fc7966-9df4-e94b-e063-6394a90a3461", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "82868-020", "generic_name": "ketorolac tromethamine", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA215788", "marketing_category": "ANDA", "marketing_start_date": "20231019", "listing_expiration_date": "20271231"}