acular

Generic: ketorolac tromethamine

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

Drug Facts

Product Profile

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

ketorolac tromethamine 5 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-2181
Product ID 0023-2181_fb99e487-9880-4bb9-9271-7bf042a4f0f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019700
Listing Expiration 2026-12-31
Marketing Start 1992-12-01

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 00232181
Hyphenated Format 0023-2181

Supplemental Identifiers

RxCUI
860107 860109
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 acular (source: ndc)
Generic Name ketorolac tromethamine (source: ndc)
Application Number NDA019700 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

0023-2181-05 1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketorolac tromethamine (5 mg/mL)

Linked Drug Pages (1)

Acular ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "fb99e487-9880-4bb9-9271-7bf042a4f0f8", "openfda": {"unii": ["4EVE5946BQ"], "rxcui": ["860107", "860109"], "spl_set_id": ["c94644d3-7b64-4f3d-a0c7-12c77466a0fc"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0023-2181-05", "marketing_start_date": "19921201"}], "brand_name": "Acular", "product_id": "0023-2181_fb99e487-9880-4bb9-9271-7bf042a4f0f8", "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": "0023-2181", "generic_name": "Ketorolac Tromethamine", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acular", "active_ingredients": [{"name": "KETOROLAC TROMETHAMINE", "strength": "5 mg/mL"}], "application_number": "NDA019700", "marketing_category": "NDA", "marketing_start_date": "19921201", "listing_expiration_date": "20261231"}