FDA.reportPublic FDA data

Tetracaine HCL

Product NDC
54288-127
11-digit product format
542880127
Labeler code
54288
Product ID
54288-127_df1a3d1f-8d9c-4ae6-9cad-527680105425
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracaine HCL
Dosage form
INJECTION
Route
SUBARACHNOID
Labeler
BPI LABS LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-06-26
Substance
TETRACAINE HYDROCHLORIDE
Active strength
10 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 HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACAINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5NF5D4OPCI
Rxcui198248

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-127-01Tetracaine HCL2 mL in 1 VIALINJECTION29
54288-127-10Tetracaine HCL10 in 1 BOXINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-127-01ML - Milliliter54288-127e92b1025-15af-42c1-b3ed-88261b44ca4812020-09-14
54288-127-10ML - Milliliter54288-127571e6a3d-2227-4e77-a9cf-aa0078d460b612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-127TETRACAINE HCL INJECTION [BPI LABS LLC]8Current NDC, Legacy NDC, 2 package rows20250213_2b3349c1-bd02-4442-9bf0-40a654bb8a80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198248tetracaine HCl 20 MG in 2 ML InjectionPSN2b3349c1-bd02-4442-9bf0-40a654bb8a809
1982482 ML tetracaine hydrochloride 10 MG/ML InjectionSCD2b3349c1-bd02-4442-9bf0-40a654bb8a809
198248tetracaine hydrochloride 20 MG per 2 ML InjectionSY2b3349c1-bd02-4442-9bf0-40a654bb8a809

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-127-01542880127012 mL in 1 VIAL2 mlHistorical
54288-127-105428801271010 VIAL in 1 BOX (54288-127-10) / 2 mL in 1 VIAL (54288-127-01) 10 vial2020-06-260000-00-00NoNoCurrent