Proparacaine Hydrochloride

Product NDC
52959-705
11-digit product format
529590705
Labeler code
52959
Product ID
52959-705_a979a931-8857-48a2-b369-d17c814d7ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040074
Marketing category
ANDA
Marketing start
1995-09-29
Marketing end
0000-00-00
Substance
PROPARACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Local Anesthesia [PE],Local Anesthetic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
52959-705-012019-11-13C16284748780-197449f38-b8d9-f6ea-e053-dbdaa90aa703Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-705-01Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS12
52959-705-01Proparacaine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-705PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20120423_522987a1-d52e-4819-9ce4-53fd17c126c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN522987a1-d52e-4819-9ce4-53fd17c126c22
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD522987a1-d52e-4819-9ce4-53fd17c126c22
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY522987a1-d52e-4819-9ce4-53fd17c126c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-705-01529590705011 in 1 CARTONHistorical