Proparacaine Hydrochloride

Product NDC
50090-1923
11-digit product format
500901923
Labeler code
50090
Product ID
50090-1923_5c8706f5-f8f3-48a7-8b99-0fa722b7d178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA040074
Marketing category
ANDA
Marketing start
1995-09-29
Substance
PROPARACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Local Anesthesia [PE], Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Proparacaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPARACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU96OL57GOY
Rxcui1191013

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1923-0Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS113
50090-1923-0Proparacaine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1923-0ML - Milliliter50090-1923db88f52b-5f97-4826-b6c3-1bc5db7b721612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1923PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20231211_7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf26113
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf26113
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf26113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1923-0500901923001 BOTTLE, DROPPER in 1 CARTON (50090-1923-0) / 15 mL in 1 BOTTLE, DROPPER2015-07-150000-00-00NoNoCurrent