ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler asclemed usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ketorolac tromethamine 30 mg/mL

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-407
Product ID 76420-407_3810f05e-7fc6-bdab-e063-6294a90abba7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204216
Listing Expiration 2026-12-31
Marketing Start 2023-06-23

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 76420407
Hyphenated Format 76420-407

Supplemental Identifiers

RxCUI
1665459
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 ANDA204216 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • HOW SUPPLIED Ketorolac Tromethamine Injection, USP is supplied as follows: 60 mg/2 mL, 2 mL single-dose vial NDC 76420-407-02 (relabeled from NDC 72266-119-01*) *FOR IM USE ONLY Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature . ] Protect from light . Retain in carton until time of use. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label
source: label

Packages (0)

No package records.

Ingredients (1)

ketorolac tromethamine (30 mg/mL)

Linked Drug Pages (1)

ketorolac tromethamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "3810f05e-7fc6-bdab-e063-6294a90abba7", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["1665459"], "spl_set_id": ["47ecf0c5-b808-45c2-aa00-ceaae61da3f6"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [], "brand_name": "ketorolac tromethamine", "product_id": "76420-407_3810f05e-7fc6-bdab-e063-6294a90abba7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-407", "generic_name": "ketorolac tromethamine", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ketorolac tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "30 mg/mL"}], "application_number": "ANDA204216", "marketing_category": "ANDA", "marketing_start_date": "20230623", "listing_expiration_date": "20261231"}