Tetracaine Hydrochloride

Product NDC
70518-2741
11-digit product format
705182741
Labeler code
70518
Product ID
70518-2741_e39dfb7a-ab6e-202c-e053-2a95a90a62d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracaine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
NDA210821
Marketing category
NDA
Marketing start
2020-05-12
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2741-02022-01-31C16284748780-1d6a99b39-c991-a426-e053-dadaa90af4c2fae938d3-6b00-4025-bc0b-6cf99445358d
70518-2741-02022-01-28C16284748780-1d6a99b39-c991-a426-e053-dadaa90af4c2fae938d3-6b00-4025-bc0b-6cf99445358d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2741-0705182741001 BOTTLE in 1 CARTON (70518-2741-0) > 15 mL in 1 BOTTLE1 bottle2020-05-120000-00-00NoNoCurrent