Proparacaine hydrochloride

Product NDC
70756-193
11-digit product format
707560193
Labeler code
70756
Product ID
70756-193_7d7eab12-f721-4092-8c18-7100544ade2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lifestar Pharma LLC
Application
ANDA219136
Marketing category
ANDA
Marketing start
2025-05-21
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
70756-193-35Proparacaine hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
70756-193-35Proparacaine hydrochloride1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-193-35ML - Milliliter70756-193a93a3c65-3ef0-460e-a869-13ec713d12a712025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-193PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [LIFESTAR PHARMA LLC]4Current NDC, 2 package rows20250524_3419104b-e847-492f-a541-a810a116c408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN3419104b-e847-492f-a541-a810a116c4084
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD3419104b-e847-492f-a541-a810a116c4084
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY3419104b-e847-492f-a541-a810a116c4084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-193-35707560193351 BOTTLE, DROPPER in 1 CARTON (70756-193-35) / 15 mL in 1 BOTTLE, DROPPER2025-05-21NoNoHistorical