Proparacaine Hydrochloride

Product NDC
50090-0259
11-digit product format
500900259
Labeler code
50090
Product ID
50090-0259_3d508ac4-e0df-4467-a8ed-64ebde1cb02d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA040277
Marketing category
ANDA
Marketing start
2000-03-16
Marketing end
0000-00-00
Substance
PROPARACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Local Anesthesia [PE],Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ba0893a-4390-4124-b66b-ffd4f2b29a0eProduct name220260305

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0259-02023-01-30C16284748780-1f386c649-ea2e-0266-e053-dadaa90a7c1aProparacaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0259-0Proparacaine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS158
50090-0259-0Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0259-0ML - Milliliter50090-0259a21b473c-843b-41f5-b0f9-0f8bfe50728812021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0259PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20210219_40d864dd-ef49-4b05-883b-265a492b4d9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN40d864dd-ef49-4b05-883b-265a492b4d9c8
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD40d864dd-ef49-4b05-883b-265a492b4d9c8
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY40d864dd-ef49-4b05-883b-265a492b4d9c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0259-0500900259001 BOTTLE, DROPPER in 1 CARTON (50090-0259-0) > 15 mL in 1 BOTTLE, DROPPER2016-06-290000-00-00NoNoCurrent