FDA.reportPublic FDA data

Carbamazepine

Product NDC
60505-2807
11-digit product format
605052807
Labeler code
60505
Product ID
60505-2807_697610a8-e6e7-b0d0-ef1b-2507d5b73c53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA078986
Marketing category
ANDA
Marketing start
2012-03-23
Substance
CARBAMAZEPINE
Active strength
300 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
CARBAMAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui200131, 200133, 388311

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
60505-2807-3Carbamazepine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015
60505-2807-5Carbamazepine500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50015
60505-2807-7Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2807CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]14Current NDC, Legacy NDC, 3 package rows20240922_e91f9de3-3fdd-0a6b-71ce-53a2cc142816.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSN34f75728-b9e8-48e7-e063-6394a90afc31100
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSN4db57051-13bb-4038-ae58-e4d7f541450d100
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNd684dfd8-1e0d-47a1-bf37-ada6413815f2100
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCD34f75728-b9e8-48e7-e063-6394a90afc31100
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCD4db57051-13bb-4038-ae58-e4d7f541450d100
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDd684dfd8-1e0d-47a1-bf37-ada6413815f2100
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSY34f75728-b9e8-48e7-e063-6394a90afc31100
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYd684dfd8-1e0d-47a1-bf37-ada6413815f2100
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSY4db57051-13bb-4038-ae58-e4d7f541450d100
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYe91f9de3-3fdd-0a6b-71ce-53a2cc14281615
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNe9d282f0-8bb7-4280-b83d-b70d83a04b931
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDe9d282f0-8bb7-4280-b83d-b70d83a04b931
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYe9d282f0-8bb7-4280-b83d-b70d83a04b931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-2807-36050528070330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2807-3) 2012-03-232023-03-31NoNoCurrent
60505-2807-560505280705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2807-5) 2012-03-232023-03-31NoNoCurrent
60505-2807-760505280707120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2807-7) 2012-03-232023-03-31NoNoCurrent