ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketorolac tromethamine 10 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-811
Product ID 62135-811_453ddff7-832e-d00f-e063-6394a90a734a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210616
Listing Expiration 2026-12-31
Marketing Start 2018-08-16

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 62135811
Hyphenated Format 62135-811

Supplemental Identifiers

RxCUI
834022
UPC
0362135811600
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 ANDA210616 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (62135-811-60)
source: ndc

Packages (1)

62135-811-60 60 TABLET in 1 BOTTLE (62135-811-60)

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": "453ddff7-832e-d00f-e063-6394a90a734a", "openfda": {"upc": ["0362135811600"], "unii": ["4EVE5946BQ"], "rxcui": ["834022"], "spl_set_id": ["3855f527-fd6c-4f24-a4b4-cd47eec1193d"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (62135-811-60)", "package_ndc": "62135-811-60", "marketing_start_date": "20240815"}], "brand_name": "Ketorolac Tromethamine", "product_id": "62135-811_453ddff7-832e-d00f-e063-6394a90a734a", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62135-811", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "10 mg/1"}], "application_number": "ANDA210616", "marketing_category": "ANDA", "marketing_start_date": "20180816", "listing_expiration_date": "20261231"}