FDA.reportPublic FDA data

carbamazepine

Product NDC
16714-065
11-digit product format
167140065
Labeler code
16714
Product ID
16714-065_dbbc5265-4038-4406-bef5-aa00aadfcc26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA205571
Marketing category
ANDA
Marketing start
2021-02-01
Substance
CARBAMAZEPINE
Active strength
400 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
carbamazepine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE400 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
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
16714-065-01carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-065-01EA - Each16714-065d27958e0-6915-4b38-ac79-cb02c2c4c08c12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-065CARBAMAZEPINE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 1 package rows20240404_c91a5a1b-5481-445b-86e8-f10109ac3937.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSNc91a5a1b-5481-445b-86e8-f10109ac39375
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSNc91a5a1b-5481-445b-86e8-f10109ac39375
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSNc91a5a1b-5481-445b-86e8-f10109ac39375
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCDc91a5a1b-5481-445b-86e8-f10109ac39375
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCDc91a5a1b-5481-445b-86e8-f10109ac39375
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCDc91a5a1b-5481-445b-86e8-f10109ac39375
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSYc91a5a1b-5481-445b-86e8-f10109ac39375
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSYc91a5a1b-5481-445b-86e8-f10109ac39375
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSYc91a5a1b-5481-445b-86e8-f10109ac39375

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-065-0116714006501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-065-01) 2021-02-010000-00-00NoNoCurrent