ACULAR

Product NDC
21695-463
11-digit product format
216950463
Labeler code
21695
Product ID
21695-463_8014fa52-6180-4365-8285-0943a036a6f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp.
Application
NDA019700
Marketing category
NDA
Marketing start
1992-11-09
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
5 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-463-052019-09-24C16284748780-1934fe258-4c17-48b1-e053-8cdaa90a720a8014fa52-6180-4365-8285-0943a036a6f6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-463-05ACULAR5 mL in 1 BOTTLESOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-463-05ML - Milliliter21695-463b136cf6c-4403-4f29-a666-5f4efe57e45512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-463ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100908_8014fa52-6180-4365-8285-0943a036a6f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860109ACULAR 0.5 % Ophthalmic SolutionPSN8014fa52-6180-4365-8285-0943a036a6f61
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionPSN8014fa52-6180-4365-8285-0943a036a6f61
860109ketorolac tromethamine 5 MG/ML Ophthalmic Solution [Acular]SBD8014fa52-6180-4365-8285-0943a036a6f61
860107ketorolac tromethamine 5 MG/ML Ophthalmic SolutionSCD8014fa52-6180-4365-8285-0943a036a6f61
860109Acular 0.5 % Ophthalmic SolutionSY8014fa52-6180-4365-8285-0943a036a6f61
860109Acular 5 MG/ML Ophthalmic SolutionSY8014fa52-6180-4365-8285-0943a036a6f61
860107ketorolac tromethamine 0.5 % Ophthalmic SolutionSY8014fa52-6180-4365-8285-0943a036a6f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-463-05216950463055 mL in 1 BOTTLE5 mlHistorical