FDA.reportPublic FDA data

CARBAMAZEPINE ER

Product NDC
35561-355
11-digit product format
355610355
Labeler code
35561
Product ID
35561-355_5094cfb0-cf09-008b-e063-6394a90a402f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bostal LLC
Application
ANDA215591
Marketing category
ANDA
Marketing start
2022-03-31
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 ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35561-355-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-355-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-355-122026-01-29C16284748780-149896155-c2f9-586f-e063-e6dba90add90Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35561-355-12CARBAMAZEPINE ER100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
35561-355-13CARBAMAZEPINE ER500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
35561-355-26CARBAMAZEPINE ER30 in 1 CARTONTABLET, EXTENDED RELEASE309
35561-355-99CARBAMAZEPINE ER125729 in 1 DRUMTABLET, EXTENDED RELEASE1257299

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-355CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [AUSTARPHARMA LLC]4Current NDC, Legacy NDC, 4 package rows20241027_b48741b3-0889-47b8-a26e-b12614f6e7fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSNb48741b3-0889-47b8-a26e-b12614f6e7fc9
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSNb48741b3-0889-47b8-a26e-b12614f6e7fc9
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSNb48741b3-0889-47b8-a26e-b12614f6e7fc9
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCDb48741b3-0889-47b8-a26e-b12614f6e7fc9
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCDb48741b3-0889-47b8-a26e-b12614f6e7fc9
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCDb48741b3-0889-47b8-a26e-b12614f6e7fc9
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSYb48741b3-0889-47b8-a26e-b12614f6e7fc9
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSYb48741b3-0889-47b8-a26e-b12614f6e7fc9
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSYb48741b3-0889-47b8-a26e-b12614f6e7fc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35561-355-1235561035512100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12) 2022-03-310000-00-00NoNoCurrent
35561-355-1335561035513500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-13) 2025-04-09NoNoHistorical
35561-355-263556103552630 in 1 CARTONHistorical
35561-355-9935561035599125729 TABLET, EXTENDED RELEASE in 1 DRUM (35561-355-99) 2025-04-27NoNoHistorical