FDA.reportPublic FDA data

Carbamazepine

Product NDC
62559-485
11-digit product format
625590485
Labeler code
62559
Product ID
62559-485_c1876184-0323-4b06-b459-603b40c0c002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA076697
Marketing category
ANDA
Marketing start
2026-04-13
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
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
62559-485-12Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-485-12EA - Each62559-485e0206849-3c70-4732-a51e-c774ca24da3912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNc1876184-0323-4b06-b459-603b40c0c0021
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNc1876184-0323-4b06-b459-603b40c0c0021
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNc1876184-0323-4b06-b459-603b40c0c0021
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDc1876184-0323-4b06-b459-603b40c0c0021
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDc1876184-0323-4b06-b459-603b40c0c0021
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDc1876184-0323-4b06-b459-603b40c0c0021
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYc1876184-0323-4b06-b459-603b40c0c0021
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYc1876184-0323-4b06-b459-603b40c0c0021
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYc1876184-0323-4b06-b459-603b40c0c0021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-485-1262559048512120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-485-12) 2026-04-13NoNoHistorical