FDA.reportPublic FDA data

Rhopressa

Product NDC
70727-497
11-digit product format
707270497
Labeler code
70727
Product ID
70727-497_82acde68-4935-4dc9-82ff-9ff7f449f893
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
netarsudil
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC; TOPICAL
Labeler
Alcon Laboratories, Inc.
Application
NDA208254
Marketing category
NDA
Marketing start
2017-12-18
Substance
NETARSUDIL MESYLATE
Active strength
.2 mg/mL
Pharmacologic classes
Rho Kinase Inhibitor [EPC], Rho Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rhopressa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NETARSUDIL MESYLATE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVL756B1K0U
Rxcui1992868, 1992873

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
203382e3-d801-4f70-866f-ebe316583560Product name120190624
dc99c89e-d489-4ded-8898-111a91f10877Product name120180221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70727-497-25Rhopressa1 in 1 CARTONSOLUTION/ DROPS117
70727-497-25Rhopressa2.5 mL in 1 BOTTLESOLUTION/ DROPS2.517
70727-497-99Rhopressa1 in 1 CARTONSOLUTION/ DROPS117
70727-497-99Rhopressa2.5 mL in 1 BOTTLESOLUTION/ DROPS2.517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70727-497-25ML - Milliliter70727-4974820c538-7f5c-4eaf-9ba9-795606dad8ff12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70727-497RHOPRESSA (NETARSUDIL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]14Current NDC, Legacy NDC, 4 package rows20240926_7d4f0e3a-5b86-4c43-982a-813b22ae7e22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992868netarsudil 0.02 % Ophthalmic SolutionPSN7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.02 % Ophthalmic SolutionPSN7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873netarsudil 0.2 MG/ML Ophthalmic Solution [Rhopressa]SBD7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992868netarsudil 0.2 MG/ML Ophthalmic SolutionSCD7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992868netarsudil 0.02 % Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992868netarsudil 0.2 MG/ML (as netarsudil dimesylate 0.28 MG/ML) Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.02 % Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.2 MG/ML (as netarsudil dimesylate 0.28 MG/ML) Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.2 MG/ML Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70727-497-25707270497251 BOTTLE in 1 CARTON (70727-497-25) / 2.5 mL in 1 BOTTLE1 bottle2017-12-180000-00-00NoNoCurrent
70727-497-99707270497991 BOTTLE in 1 CARTON (70727-497-99) / 2.5 mL in 1 BOTTLE1 bottle2017-12-180000-00-00YesNoCurrent