FDA.reportPublic FDA data

Carbamazepine

Product NDC
13668-284
11-digit product format
136680284
Labeler code
13668
Product ID
13668-284_025fe6a0-10f7-423b-a08c-716b2227789a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA212524
Marketing category
ANDA
Marketing start
2025-09-10
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
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
CARBAMAZEPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui199378, 402505, 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
13668-284-01Carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
13668-284-05Carbamazepine500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
13668-284-22Carbamazepine8 in 1 BLISTER PACKTABLET, EXTENDED RELEASE87
13668-284-23Carbamazepine80 in 1 CARTONTABLET, EXTENDED RELEASE807
13668-284-30Carbamazepine30 in 1 BOTTLETABLET, EXTENDED RELEASE307
13668-284-60Carbamazepine60 in 1 BOTTLETABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-284-01EA - Each13668-284810cd4ed-a1ae-476f-97c4-69e0887d09b012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN7c4860c1-daba-4e0f-97fd-d30cbc8603a27
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD7c4860c1-daba-4e0f-97fd-d30cbc8603a27
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD7c4860c1-daba-4e0f-97fd-d30cbc8603a27
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD7c4860c1-daba-4e0f-97fd-d30cbc8603a27
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY7c4860c1-daba-4e0f-97fd-d30cbc8603a27
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY7c4860c1-daba-4e0f-97fd-d30cbc8603a27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-284-0113668028401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-01) 2025-09-10NoNoCurrent
13668-284-0513668028405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-05) 2025-09-10NoNoCurrent
13668-284-22136680284228 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (13668-284-22) 2025-09-10NoNoCurrent
13668-284-231366802842380 TABLET, EXTENDED RELEASE in 1 CARTON (13668-284-23) 2025-09-10NoNoCurrent
13668-284-301366802843030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-30) 2025-09-10NoNoCurrent
13668-284-601366802846060 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-284-60) 2025-09-10NoNoCurrent