FDA.reportPublic FDA data

carbamazepine

Product NDC
70771-1469
11-digit product format
707711469
Labeler code
70771
Product ID
70771-1469_83671980-7b16-469c-8b99-2dcf846df494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205571
Marketing category
ANDA
Marketing start
2019-03-12
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
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
70771-1469-1carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
70771-1469-3carbamazepine30 in 1 BOTTLETABLET, EXTENDED RELEASE307
70771-1469-4carbamazepine10 in 1 CARTONTABLET, EXTENDED RELEASE107
70771-1469-4carbamazepine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE107
70771-1469-9carbamazepine90 in 1 BOTTLETABLET, EXTENDED RELEASE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1469CARBAMAZEPINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 5 package rows20240404_d10e5f83-56db-4bc9-8c51-150a2e3e20ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSNd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSNd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSNd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCDd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCDd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCDd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSYd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSYd10e5f83-56db-4bc9-8c51-150a2e3e20ea7
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSYd10e5f83-56db-4bc9-8c51-150a2e3e20ea7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1469-170771146901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1469-1) 2019-03-120000-00-00NoNoCurrent
70771-1469-37077114690330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1469-3) 2019-03-120000-00-00NoNoCurrent
70771-1469-47077114690410 BLISTER PACK in 1 CARTON (70771-1469-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2019-03-120000-00-00NoNoCurrent
70771-1469-97077114690990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1469-9) 2019-03-120000-00-00NoNoCurrent