FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
60687-583
11-digit product format
606870583
Labeler code
60687
Product ID
60687-583_33789d2e-f734-3430-e063-6294a90a71d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA211623
Marketing category
ANDA
Marketing start
2022-01-05
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
Rxcui402505, 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
60687-583-11CARBAMAZEPINE1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
60687-583-21CARBAMAZEPINE30 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-583-11EA - Each60687-583a214fb35-3720-4d24-a25e-8a384176a42312021-12-08
60687-583-21EA - Each60687-583505b2162-e163-4213-8b40-825d9dbd3b9612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-583CARBAMAZEPINE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20250427_7108d630-89bc-4815-b6fb-a1f4676c496e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN7108d630-89bc-4815-b6fb-a1f4676c496e3
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN7108d630-89bc-4815-b6fb-a1f4676c496e3
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD7108d630-89bc-4815-b6fb-a1f4676c496e3
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD7108d630-89bc-4815-b6fb-a1f4676c496e3
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY7108d630-89bc-4815-b6fb-a1f4676c496e3
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY7108d630-89bc-4815-b6fb-a1f4676c496e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-583-11606870583111 in 1 BLISTER PACKHistorical
60687-583-216068705832130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-583-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-583-11) 30 blister pack2022-01-050000-00-00NoNoCurrent