Tetracaine Hydrochloride

Product NDC
50090-2364
11-digit product format
500902364
Labeler code
50090
Product ID
50090-2364_c7b72c56-5267-471a-8370-55a0f0122e5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tetracaine hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
NDA208135
Marketing category
NDA
Marketing start
2016-11-02
Substance
TETRACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5NF5D4OPCI
Rxcui1547771

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2364-1Tetracaine Hydrochloride4 mL in 1 BOTTLE, DROPPERSOLUTION49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2364-0ML - Milliliter50090-2364c3907b4a-9daa-4265-b624-53a41291693d12019-02-13
50090-2364-1ML - Milliliter50090-236447c14562-45dc-4fb0-8ff2-2b062c81da6112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2364TETRACAINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, 1 package rows20250213_23c40ef8-6338-46f8-aca9-1aa4f3b2207b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547771tetracaine HCl 0.5 % Ophthalmic SolutionPSN23c40ef8-6338-46f8-aca9-1aa4f3b2207b9
1547771tetracaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD23c40ef8-6338-46f8-aca9-1aa4f3b2207b9
1547771tetracaine hydrochloride 0.5 % Ophthalmic SolutionSY23c40ef8-6338-46f8-aca9-1aa4f3b2207b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-2364-1500902364014 mL in 1 BOTTLE, DROPPER (50090-2364-1) 4 ml2019-09-23NoNoHistorical