Proparacaine Hydrochloride

Product NDC
85766-056
11-digit product format
857660056
Labeler code
85766
Product ID
85766-056_502ef7c0-5f77-5d3f-e063-6294a90a1019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sportpharm LLC
Application
ANDA080027
Marketing category
ANDA
Marketing start
2000-06-05
Substance
PROPARACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Local Anesthesia [PE], Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Proparacaine Hydrochloride
Listing expiration
2027-12-31

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
85766-056-15Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS12
85766-056-15Proparacaine Hydrochloride15 mL in 1 BOTTLESOLUTION/ DROPS152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN1d257859-cd1d-485f-a4d5-dbb33c1ec1972
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD1d257859-cd1d-485f-a4d5-dbb33c1ec1972
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY1d257859-cd1d-485f-a4d5-dbb33c1ec1972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-056-15857660056151 BOTTLE in 1 CARTON (85766-056-15) / 15 mL in 1 BOTTLE1 bottle2025-08-22NoNoHistorical