Carbamazepine

Product NDC
70518-2653
11-digit product format
705182653
Labeler code
70518
Product ID
70518-2653_cc6fee50-0343-92d5-e053-2a95a90a6f4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020234
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-03-25
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2653-02023-03-13C16284748780-1f386c64a-110b-0266-e053-dadaa90a7c1a2f6f568d-174d-49d6-a319-3b1a541e92b2
70518-2653-02023-01-30C16284748780-1f386c64a-110b-0266-e053-dadaa90a7c1a2f6f568d-174d-49d6-a319-3b1a541e92b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2653-07051826530030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2653-0) 2020-03-250000-00-00NoNoCurrent