Clorotekal

Product NDC
0264-7055
11-digit product format
002647055
Labeler code
0264
Product ID
0264-7055_fffbe142-9c62-4a45-af74-cfada0daf2a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLOROPROCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL
Labeler
B. Braun Medical Inc.
Application
NDA208791
Marketing category
NDA
Marketing start
2018-05-01
Marketing end
0000-00-00
Substance
CHLOROPROCAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Ester Local Anesthetic [EPC],Esters [CS],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5d35ea28-18de-4c43-8b81-d4140e17b91aProduct name120230912
9f0ed4af-e581-4924-816e-213668654c3dProduct name120171115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-7055-05ML - Milliliter0264-7055d9e52a59-cc82-48b6-a13e-29365a5043b812018-10-11
0264-7055-10ML - Milliliter0264-70554bf9fe16-e0f7-41a2-9834-c5a2a17bdd2f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-7055CLOROTEKAL (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]6Legacy NDC20201211_90f7a095-f6db-456b-951f-9aee54c5dbc0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-7055-100026470551010 AMPULE in 1 CARTON (0264-7055-10) > 5 mL in 1 AMPULE (0264-7055-05) 10 ampule2018-05-010000-00-00NoNoCurrent