acuvail

Generic: ketorolac tromethamine

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name acuvail
Generic Name ketorolac tromethamine
Labeler allergan, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketorolac tromethamine 4.5 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-3507
Product ID 0023-3507_ee96bc53-04b7-4ea7-8fab-835ed3648561
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022427
Listing Expiration 2026-12-31
Marketing Start 2009-08-01

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 00233507
Hyphenated Format 0023-3507

Supplemental Identifiers

RxCUI
858364 858366
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 acuvail (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number NDA022427 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4.5 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSE
  • 3 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0023-3507-05 5 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSE 0023-3507-31 3 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ketorolac tromethamine (4.5 mg/mL)

Linked Drug Pages (1)

ACUVAIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "ee96bc53-04b7-4ea7-8fab-835ed3648561", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["858364", "858366"], "spl_set_id": ["3cea5803-a446-4d2c-9747-f3fb034332c8"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05)  / .4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0023-3507-05", "marketing_start_date": "20090801"}, {"sample": false, "description": "3 POUCH in 1 CARTON (0023-3507-31)  / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0023-3507-31", "marketing_start_date": "20090801"}], "brand_name": "ACUVAIL", "product_id": "0023-3507_ee96bc53-04b7-4ea7-8fab-835ed3648561", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0023-3507", "generic_name": "ketorolac tromethamine", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACUVAIL", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "4.5 mg/mL"}], "application_number": "NDA022427", "marketing_category": "NDA", "marketing_start_date": "20090801", "listing_expiration_date": "20261231"}