ketorolac tromethamine

Generic: ketorolac tromethamine

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketorolac tromethamine
Generic Name ketorolac tromethamine
Labeler sola pharmaceuticals, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 5 mg/mL

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-790
Product ID 70512-790_4572771c-8bb4-abe9-e063-6294a90a6c69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218204
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

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 70512790
Hyphenated Format 70512-790

Supplemental Identifiers

RxCUI
860107
UPC
0370512790103 0370512790059
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 ANDA218204 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (70512-790-03) / 3 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (70512-790-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (70512-790-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

70512-790-03 1 BOTTLE, DROPPER in 1 CARTON (70512-790-03) / 3 mL in 1 BOTTLE, DROPPER 70512-790-05 1 BOTTLE, DROPPER in 1 CARTON (70512-790-05) / 5 mL in 1 BOTTLE, DROPPER 70512-790-10 1 BOTTLE, DROPPER in 1 CARTON (70512-790-10) / 10 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": "4572771c-8bb4-abe9-e063-6294a90a6c69", "openfda": {"upc": ["0370512790103", "0370512790059"], "unii": ["4EVE5946BQ"], "rxcui": ["860107"], "spl_set_id": ["b08a46f3-36c9-405d-a963-9739a5c87f9c"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (70512-790-03)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "70512-790-03", "marketing_start_date": "20240415"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (70512-790-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "70512-790-05", "marketing_start_date": "20240415"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (70512-790-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "70512-790-10", "marketing_start_date": "20240415"}], "brand_name": "Ketorolac Tromethamine", "product_id": "70512-790_4572771c-8bb4-abe9-e063-6294a90a6c69", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70512-790", "generic_name": "ketorolac tromethamine", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketorolac Tromethamine", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "ANDA218204", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}