FDA.reportPublic FDA data

Carbamazepine

Product NDC
60505-2806
11-digit product format
605052806
Labeler code
60505
Product ID
60505-2806_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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 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
60505-2806-3Carbamazepine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015
60505-2806-7Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12015
60505-2806-8Carbamazepine1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2806CARBAMAZEPINE 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
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSN0ccee1ed-3d7c-452b-9519-c1ddb92893df100
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSN46eef194-760d-43ea-86c5-341927277c91100
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCD0ccee1ed-3d7c-452b-9519-c1ddb92893df100
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCD46eef194-760d-43ea-86c5-341927277c91100
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSY0ccee1ed-3d7c-452b-9519-c1ddb92893df100
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSY46eef194-760d-43ea-86c5-341927277c91100
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
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSN2676f950-48b4-4bef-a792-ea4570de9aa65
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCD2676f950-48b4-4bef-a792-ea4570de9aa65
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSY2676f950-48b4-4bef-a792-ea4570de9aa65
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-2806-36050528060330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2806-3) 2012-03-232023-03-31NoNoCurrent
60505-2806-760505280607120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2806-7) 2012-03-232023-03-31NoNoCurrent
60505-2806-8605052806081000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2806-8) 2012-03-232023-03-31NoNoCurrent