FDA.reportPublic FDA data

Carbamazepine

Product NDC
60505-2805
11-digit product format
605052805
Labeler code
60505
Product ID
60505-2805_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
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
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
CARBAMAZEPINE100 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
60505-2805-3Carbamazepine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015
60505-2805-7Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12015
60505-2805-8Carbamazepine1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2805-7EA - Each60505-2805a240e407-2f26-47eb-a74b-56925f8122d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
GELATININACTIVE INGREDIENT2G86QN327LCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2805CARBAMAZEPINE 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
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSN1a8c4f15-9e75-4919-ac67-06102b82dd92100
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCD1a8c4f15-9e75-4919-ac67-06102b82dd92100
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSY1a8c4f15-9e75-4919-ac67-06102b82dd92100
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
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSN47d0ea82-9974-4d41-9ae1-5f1b11419a331
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCD47d0ea82-9974-4d41-9ae1-5f1b11419a331
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSY47d0ea82-9974-4d41-9ae1-5f1b11419a331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-2805-36050528050330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2805-3) 2012-03-232023-03-31NoNoCurrent
60505-2805-760505280507120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2805-7) 2012-03-232023-03-31NoNoCurrent
60505-2805-8605052805081000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2805-8) 2012-03-232023-03-31NoNoCurrent