Tetracaine

Product NDC
17478-045
11-digit product format
174780045
Labeler code
17478
Product ID
17478-045_8abd8c3a-58a0-46bd-96d6-6cef7b9bc294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracaine HCl
Dosage form
INJECTION
Route
SUBARACHNOID
Labeler
Akorn
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-06-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-045-322024-01-30C16284748780-11030e365-6c6a-111a-e063-dadaa90a10e2TETRACAINE 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-045-32Tetracaine25 in 1 CARTONINJECTION257
17478-045-32Tetracaine2 mL in 1 AMPULEINJECTION27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-045-32ML - Milliliter17478-0452ec0e18e-4c05-4fc0-82dd-2f0ab22635d012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tetracaine hydrochlorideACTIVE INGREDIENT5NF5D4OPCITETRACAINE (TETRACAINE HCL) INJECTION [AKORN, INC.]1
tetracaineACTIVE MOIETY0619F35CGVTETRACAINE (TETRACAINE HCL) INJECTION [AKORN, INC.]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTETRACAINE (TETRACAINE HCL) INJECTION [AKORN, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XTETRACAINE (TETRACAINE HCL) INJECTION [AKORN, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITETRACAINE (TETRACAINE HCL) INJECTION [AKORN, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RTETRACAINE (TETRACAINE HCL) INJECTION [AKORN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-045TETRACAINE (TETRACAINE HCL) INJECTION [AKORN]7Legacy NDC, 2 package rows20220919_b29124f7-c238-4961-b810-f4e7fabe4bb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198248tetracaine HCl 20 MG in 2 ML InjectionPSNb29124f7-c238-4961-b810-f4e7fabe4bb17
1982482 ML tetracaine hydrochloride 10 MG/ML InjectionSCDb29124f7-c238-4961-b810-f4e7fabe4bb17
198248tetracaine hydrochloride 20 MG per 2 ML InjectionSYb29124f7-c238-4961-b810-f4e7fabe4bb17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-045-321747800453225 AMPULE in 1 CARTON (17478-045-32) > 2 mL in 1 AMPULE25 ampule2010-06-010000-00-00NoNoCurrent