FDA.reportPublic FDA data

Carbamazepine

Product NDC
70518-1433
11-digit product format
705181433
Labeler code
70518
Product ID
70518-1433_4d60d4e4-3b2f-555f-e063-6294a90a7e2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075687
Marketing category
ANDA
Marketing start
2018-09-24
Substance
CARBAMAZEPINE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308973

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1433-0Carbamazepine30 in 1 BLISTER PACKTABLET, CHEWABLE3019
70518-1433-1Carbamazepine180 in 1 BOTTLE, PLASTICTABLET, CHEWABLE18019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1433-0EA - Each70518-1433d0935eba-50b8-4289-86ba-1f98d39da02412026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1433CARBAMAZEPINE TABLET, CHEWABLE [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 2 package rows20250523_d0121be3-b904-41d3-a81a-292aa4176491.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSNd0121be3-b904-41d3-a81a-292aa417649119
308973carbamazepine 100 MG Chewable TabletSCDd0121be3-b904-41d3-a81a-292aa417649119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1433-07051814330030 TABLET, CHEWABLE in 1 BLISTER PACK (70518-1433-0) 2018-09-240000-00-00NoNoCurrent
70518-1433-170518143301180 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70518-1433-1) 2020-02-060000-00-00NoNoCurrent