ACUVUE Theravision with Ketotifen

Product NDC
60123-019
11-digit product format
601230019
Labeler code
60123
Product ID
60123-019_194326a6-ec33-4dc6-89c8-5c8393b83c3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
DRUG-ELUTING CONTACT LENS
Route
INTRAOCULAR
Labeler
Johnson & Johnson Vision Care, Inc.
Application
NDA022388
Marketing category
NDA
Marketing start
2022-02-28
Marketing end
0000-00-00
Substance
KETOTIFEN FUMARATE
Active strength
0 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60123-019-30ACUVUE Theravision with Ketotifen30 in 1 CARTONdrug-eluting contact lens302
60123-019-30ACUVUE Theravision with Ketotifen1 in 1 BLISTER PACKdrug-eluting contact lens12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60123-019ACUVUE THERAVISION WITH KETOTIFEN (KETOTIFEN FUMARATE) DRUG-ELUTING CONTACT LENS [JOHNSON & JOHNSON VISION CARE, INC.]2Legacy NDC, 2 package rows20220615_d222d68c-911e-48a9-9bde-a1ca7e992d18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604049ACUVUE Theravision 19 MCG Drug-Eluting Contact LensPSNd222d68c-911e-48a9-9bde-a1ca7e992d182
2604045ketotifen 19 MG Drug-Eluting Contact LensPSNd222d68c-911e-48a9-9bde-a1ca7e992d182
2604049ketotifen 0.019 MG Drug-Eluting Contact Lens [Acuvue Theravision]SBDd222d68c-911e-48a9-9bde-a1ca7e992d182
2604045ketotifen 0.019 MG Drug-Eluting Contact LensSCDd222d68c-911e-48a9-9bde-a1ca7e992d182
2604049Acuvue Theravision 0.019 MG Drug-Eluting Contact LensSYd222d68c-911e-48a9-9bde-a1ca7e992d182
2604049Acuvue Theravision 19 MCG Drug-Eluting Contact LensSYd222d68c-911e-48a9-9bde-a1ca7e992d182
2604045ketotifen 19 MG (as ketotifen fumarate 43 MCG) Drug-Eluting Contact LensSYd222d68c-911e-48a9-9bde-a1ca7e992d182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60123-019-306012300193030 BLISTER PACK in 1 CARTON (60123-019-30) > 1 DRUG-ELUTING CONTACT LENS in 1 BLISTER PACK30 blister pack2022-02-280000-00-00NoNoCurrent