FDA.reportPublic FDA data

Carbamazepine

Product NDC
60290-059
11-digit product format
602900059
Labeler code
60290
Product ID
60290-059_52b7a79f-1c50-a01a-e063-6394a90aae4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA216594
Marketing category
ANDA
Marketing start
2022-08-20
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
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
60290-059-01Carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
60290-059-02Carbamazepine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60290-059CARBAMAZEPINE (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [UMEDICA LABORATORIES PRIVATE LIMITED]3Current NDC, 2 package rows20241225_48080efd-1781-4585-83f8-c43957ac63b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN48080efd-1781-4585-83f8-c43957ac63b36
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN48080efd-1781-4585-83f8-c43957ac63b36
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN48080efd-1781-4585-83f8-c43957ac63b36
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD48080efd-1781-4585-83f8-c43957ac63b36
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD48080efd-1781-4585-83f8-c43957ac63b36
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD48080efd-1781-4585-83f8-c43957ac63b36
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY48080efd-1781-4585-83f8-c43957ac63b36
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY48080efd-1781-4585-83f8-c43957ac63b36
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY48080efd-1781-4585-83f8-c43957ac63b36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60290-059-0160290005901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-059-01) 2022-08-20NoNoCurrent
60290-059-02602900059021000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-059-02) 2022-08-20NoNoCurrent