FDA.reportPublic FDA data

Proparacaine Hydrochloride

Product NDC
70069-601
11-digit product format
700690601
Labeler code
70069
Product ID
70069-601_abb9ea27-1536-41b3-b84e-839796fdf710
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Somerset Therapeutics, LLC
Application
ANDA215816
Marketing category
ANDA
Marketing start
2024-10-10
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
70069-601-01Proparacaine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS15
70069-601-01Proparacaine Hydrochloride15 mL in 1 BOTTLESOLUTION/ DROPS155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-601-01ML - Milliliter70069-6010e47e4fb-6f2b-4c99-b20c-b75d5121bde912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-601PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]5Current NDC, 2 package rows20241012_968a6e4e-814f-41f8-ae22-aa5a82179a6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN968a6e4e-814f-41f8-ae22-aa5a82179a6c5
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD968a6e4e-814f-41f8-ae22-aa5a82179a6c5
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY968a6e4e-814f-41f8-ae22-aa5a82179a6c5
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN4ae89863-233f-4015-92da-aad0f2a876772
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD4ae89863-233f-4015-92da-aad0f2a876772
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY4ae89863-233f-4015-92da-aad0f2a876772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-601-01700690601011 BOTTLE in 1 CARTON (70069-601-01) / 15 mL in 1 BOTTLE1 bottle2024-10-10NoNoHistorical