FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
70518-3146
11-digit product format
705183146
Labeler code
70518
Product ID
70518-3146_51116fe8-6467-b482-e063-6294a90aa539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075948
Marketing category
ANDA
Marketing start
2021-07-13
Substance
CARBAMAZEPINE
Active strength
200 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
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308979

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3146-02023-02-13C16284748780-1f386c649-e907-0266-e053-dadaa90a7c1aCARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
70518-3146-02023-02-13C16284748780-1f386c649-e907-0266-e053-dadaa90a7c1aCARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
70518-3146-02023-01-30C16284748780-1f386c649-e907-0266-e053-dadaa90a7c1aCARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
70518-3146-02023-01-30C16284748780-1f386c649-e907-0266-e053-dadaa90a7c1aCARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3146-0CARBAMAZEPINE100 in 1 BOXTABLET1009
70518-3146-1CARBAMAZEPINE1 in 1 POUCHTABLET19
70518-3146-2CARBAMAZEPINE30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3146CARBAMAZEPINE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250424_52cf3ba9-0a7c-4809-830e-af93d1532726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN52cf3ba9-0a7c-4809-830e-af93d15327269
308979carbamazepine 200 MG Oral TabletSCD52cf3ba9-0a7c-4809-830e-af93d15327269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3146-070518314600100 POUCH in 1 BOX (70518-3146-0) / 1 TABLET in 1 POUCH (70518-3146-1) 100 pouch2021-07-130000-00-00NoNoCurrent
70518-3146-1705183146011 in 1 POUCHHistorical
70518-3146-27051831460230 in 1 BLISTER PACKHistorical