FDA.reportPublic FDA data

Carbamazepine ER

Product NDC
62135-928
11-digit product format
621350928
Labeler code
62135
Product ID
62135-928_458c15a3-d257-681b-e063-6294a90a282a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA215591
Marketing category
ANDA
Marketing start
2022-03-31
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
Carbamazepine ER
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
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
62135-928-60Carbamazepine ER60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-928-60EA - Each62135-928ff397572-0ed5-4699-8c59-56156a471bc112024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-928CARBAMAZEPINE ER TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC]1Current NDC, 1 package rows20241120_bf2bff52-d1ae-4b81-951c-7d39d3c5058f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSNbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSNbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSNbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCDbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCDbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCDbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSYbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSYbf2bff52-d1ae-4b81-951c-7d39d3c5058f2
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSYbf2bff52-d1ae-4b81-951c-7d39d3c5058f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-928-606213509286060 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-928-60) 2024-11-06NoNoHistorical