Proparacaine Hydrochloride

Product NDC
17478-263
11-digit product format
174780263
Labeler code
17478
Product ID
17478-263_747aceb1-08a4-491e-83eb-db9130b82973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
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
2023-12-31
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
17478-263-122024-01-30C16284748780-11030e365-0a22-111a-e063-dadaa90a10e2Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-263-12Proparacaine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS159
17478-263-12Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-263-12ML - Milliliter17478-2630f325a2c-752e-41bf-83e3-f6dea7dbee9c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-263PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [AKORN]9Legacy NDC, 2 package rows20220911_37cde651-2549-43f3-97b9-cdc442a0aa7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN37cde651-2549-43f3-97b9-cdc442a0aa7a9
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD37cde651-2549-43f3-97b9-cdc442a0aa7a9
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY37cde651-2549-43f3-97b9-cdc442a0aa7a9
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
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSNc1e57227-6c96-4922-973e-74838ab4c7951
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCDc1e57227-6c96-4922-973e-74838ab4c7951
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSYc1e57227-6c96-4922-973e-74838ab4c7951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-263-12174780263121 BOTTLE, DROPPER in 1 CARTON (17478-263-12) > 15 mL in 1 BOTTLE, DROPPER2000-03-160000-00-00NoNoCurrent