Proparacaine Hydrochloride

Product NDC
13985-611
11-digit product format
139850611
Labeler code
13985
Product ID
13985-611_38a62501-a39a-435e-8623-6417beaf55ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MWI
Application
ANDA040277
Marketing category
ANDA
Marketing start
2015-03-27
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
13985-611-152024-01-30C16284748780-11030e365-3ed9-111a-e063-dadaa90a10e2apexa™ Proparacaine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-611-15Proparacaine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
13985-611-15Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Proparacaine HydrochlorideACTIVE INGREDIENTU96OL57GOYPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
ProparacaineACTIVE MOIETYB4OB0JHI1XPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1
WaterINACTIVE INGREDIENT059QF0KO0RPROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-611PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [MWI]4Legacy NDC, 2 package rows20220205_66e8723a-620c-42ed-a43e-cfa30014e1dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN66e8723a-620c-42ed-a43e-cfa30014e1dc4
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD66e8723a-620c-42ed-a43e-cfa30014e1dc4
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY66e8723a-620c-42ed-a43e-cfa30014e1dc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13985-611-15139850611151 BOTTLE, DROPPER in 1 CARTON (13985-611-15) > 15 mL in 1 BOTTLE, DROPPER2015-03-270000-00-00NoNoCurrent