FDA.reportPublic FDA data

VUITY

Product NDC
0074-7098
11-digit product format
000747098
Labeler code
0074
Product ID
0074-7098_ed4cf150-c4b6-4d26-9326-e3a3490de489
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
AbbVie Inc.
Application
NDA214028
Marketing category
NDA
Marketing start
2021-10-28
Marketing end
2026-09-30
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
12.5 mg/mL
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VUITY

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE12.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WW6D218XJ
Rxcui2584552, 2584557

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92fc48b4-3815-4611-a8be-f74b29f9b350Product name220260130
c8f45a17-34ae-46eb-871b-470615085910Product name120250630
dad00d81-2cbe-bbab-dd06-a12043b5e56dProduct name420210512
419b812f-d1a6-2de2-5dee-bec68d6ec699Product name220200123
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-7098-01VUITY1 in 1 BOXSOLUTION/ DROPS114
0074-7098-02VUITY2.5 mL in 1 BOTTLESOLUTION/ DROPS2.514
0074-7098-03VUITY3 in 1 BOXSOLUTION/ DROPS314
0074-7098-04VUITY1 in 1 CARTONSOLUTION/ DROPS114
0074-7098-05VUITY1 in 1 CARTONSOLUTION/ DROPS114
0074-7098-05VUITY1.5 mL in 1 BOTTLESOLUTION/ DROPS1.514
0074-7098-06VUITY5 mL in 1 BOTTLESOLUTION/ DROPS514
0074-7098-06VUITY1 in 1 CARTONSOLUTION/ DROPS114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-7098-02ML - Milliliter0074-7098beeb9de3-1b72-4539-91af-d8c61165280712023-02-06
0074-7098-04ML - Milliliter0074-709827a384ed-974a-479b-a116-8cb5e7a70b9e12021-12-08
0074-7098-06ML - Milliliter0074-70983e038256-20c6-4f5d-b5a4-e60acf2343e812023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-7098VUITY (PILOCARPINE HYDROCHLORIDE) SOLUTION/ DROPS [ABBVIE INC.]13Current NDC, Legacy NDC, 8 package rows20230404_8d806897-8a2a-4518-8c68-0ec3b778de50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584552pilocarpine HCl 1.25 % Ophthalmic SolutionPSN8d806897-8a2a-4518-8c68-0ec3b778de5014
2584557Vuity 1.25 % Ophthalmic SolutionPSN8d806897-8a2a-4518-8c68-0ec3b778de5014
2584557pilocarpine hydrochloride 12.5 MG/ML Ophthalmic Solution [Vuity]SBD8d806897-8a2a-4518-8c68-0ec3b778de5014
2584552pilocarpine hydrochloride 12.5 MG/ML Ophthalmic SolutionSCD8d806897-8a2a-4518-8c68-0ec3b778de5014
2584552pilocarpine hydrochloride 1.25 % Ophthalmic SolutionSY8d806897-8a2a-4518-8c68-0ec3b778de5014
2584557Vuity 12.5 MG/ML Ophthalmic SolutionSY8d806897-8a2a-4518-8c68-0ec3b778de5014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-7098-01000747098011 BOTTLE in 1 BOX (0074-7098-01) > 5 mL in 1 BOTTLE1 bottle2021-10-280000-00-00NoNoCurrent
0074-7098-02000747098022.5 mL in 1 BOTTLE2.5 mlHistorical
0074-7098-03000747098033 BOTTLE in 1 BOX (0074-7098-03) > 5 mL in 1 BOTTLE3 bottle2021-10-280000-00-00NoNoCurrent
0074-7098-04000747098041 BOTTLE in 1 CARTON (0074-7098-04) / 2.5 mL in 1 BOTTLE (0074-7098-02) 1 bottle2021-10-282026-09-30NoNoCurrent
0074-7098-05000747098051 BOTTLE in 1 CARTON (0074-7098-05) > 1.5 mL in 1 BOTTLE1 bottle2021-10-280000-00-00YesNoCurrent
0074-7098-06000747098061 BOTTLE in 1 CARTON (0074-7098-06) / 5 mL in 1 BOTTLE1 bottle2023-03-082026-09-30NoNoHistorical