TETRACAINE HYDROCHLORIDE

Product NDC
76519-1118
11-digit product format
765191118
Labeler code
76519
Product ID
76519-1118_7436cc22-e6a5-cb4f-e053-2a91aa0af764
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TETRACAINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-01-28
Marketing end
0000-00-00
Substance
TETRACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
76519-1118-52020-01-31C16284748780-19d75b9cf-df19-f424-e053-dadaa90a57ce1118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1118-5TETRACAINE HYDROCHLORIDE15 mL in 1 BOTTLE, DROPPERSOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1118TETRACAINE HYDROCHLORIDE SOLUTION [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20180828_7436cc22-e6a4-cb4f-e053-2a91aa0af764.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547771tetracaine HCl 0.5 % Ophthalmic SolutionPSN7436cc22-e6a4-cb4f-e053-2a91aa0af7641
1547771tetracaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD7436cc22-e6a4-cb4f-e053-2a91aa0af7641
1547771tetracaine hydrochloride 0.5 % Ophthalmic SolutionSY7436cc22-e6a4-cb4f-e053-2a91aa0af7641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76519-1118-57651911180515 mL in 1 BOTTLE, DROPPER15 mlHistorical