Proparacaine Hydrochloride

Product NDC
50090-1931
11-digit product format
500901931
Labeler code
50090
Product ID
50090-1931_f8c7ce3f-19ec-4a43-84ee-c3551b96c4d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA080027
Marketing category
ANDA
Marketing start
2000-06-05
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
50090-1931-02023-01-30C16284748780-1f386c64a-00fe-0266-e053-dadaa90a7c1aProparacaine Hydrochloride Ophthalmic Solution USP, 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1931-0Proparacaine Hydrochloride15 mL in 1 BOTTLESOLUTION/ DROPS158
50090-1931-0Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1931-0ML - Milliliter50090-19311dd0aee9-1b85-4de0-9cc3-b7c95e1a8b8f12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1931PROPARACAINE HYDROCHLORIDE (PROPARACAINE HYDROCHLORIDE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20210227_23e7d225-ff17-4516-b9a7-9fd046712171.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN23e7d225-ff17-4516-b9a7-9fd0467121718
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD23e7d225-ff17-4516-b9a7-9fd0467121718
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY23e7d225-ff17-4516-b9a7-9fd0467121718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1931-0500901931001 BOTTLE in 1 CARTON (50090-1931-0) > 15 mL in 1 BOTTLE1 bottle2015-07-160000-00-00NoNoCurrent