FDA.reportPublic FDA data

Carbamazepin

Product NDC
0832-6023
11-digit product format
008326023
Labeler code
0832
Product ID
0832-6023_8bbf550a-a827-45cc-85a5-4795ec14e2e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA213311
Marketing category
ANDA
Marketing start
2021-04-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui199378, 402505, 402506

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-6023-11Carbamazepin100 in 1 BOTTLETABLET, EXTENDED RELEASE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-6023-11EA - Each0832-602334200a64-c8dc-4eee-9444-6be579ed94a012021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-6023CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPIN (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]3Current NDC, Legacy NDC, 1 package rows20231116_282c954f-e34a-4bd5-b5eb-771e3c56936f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN282c954f-e34a-4bd5-b5eb-771e3c56936f3
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN282c954f-e34a-4bd5-b5eb-771e3c56936f3
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN282c954f-e34a-4bd5-b5eb-771e3c56936f3
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD282c954f-e34a-4bd5-b5eb-771e3c56936f3
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD282c954f-e34a-4bd5-b5eb-771e3c56936f3
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD282c954f-e34a-4bd5-b5eb-771e3c56936f3
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY282c954f-e34a-4bd5-b5eb-771e3c56936f3
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY282c954f-e34a-4bd5-b5eb-771e3c56936f3
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY282c954f-e34a-4bd5-b5eb-771e3c56936f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-6023-1100832602311100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0832-6023-11) 2021-04-130000-00-00NoNoCurrent