FDA.reportPublic FDA data

Carbamazepine

Product NDC
51672-4124
11-digit product format
516724124
Labeler code
51672
Product ID
51672-4124_48fd19fc-5d5b-0d24-e063-6294a90a0aa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078115
Marketing category
ANDA
Marketing start
2009-03-31
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
Rxcui197442, 199378, 308973, 308976, 308979, 402505, 402506

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4124-1Carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE10011
51672-4124-3Carbamazepine1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011
51672-4124-6Carbamazepine30 in 1 BOTTLETABLET, EXTENDED RELEASE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4124-1EA - Each51672-412432278918-29bd-4684-9096-abd16c60f01e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbamazepineACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
CarbamazepineACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
diethyl phthalateINACTIVE INGREDIENTUF064M00AFCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
sorbitolINACTIVE INGREDIENT506T60A25RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
sucroseINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
waterINACTIVE INGREDIENT059QF0KO0RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5
xanthan gumINACTIVE INGREDIENTTTV12P4NEECARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4124CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 3 package rows20241127_0526a054-3eda-49b4-b390-7d5d16e30af8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
308973carBAMazepine 100 MG Chewable TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSN0526a054-3eda-49b4-b390-7d5d16e30af811
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
197442carBAMazepine 200 MG Chewable TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
308979carBAMazepine 200 MG Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN0526a054-3eda-49b4-b390-7d5d16e30af811
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
308973carbamazepine 100 MG Chewable TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
308976carbamazepine 20 MG/ML Oral SuspensionSCD0526a054-3eda-49b4-b390-7d5d16e30af811
197442carbamazepine 200 MG Chewable TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
308979carbamazepine 200 MG Oral TabletSCD0526a054-3eda-49b4-b390-7d5d16e30af811
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY0526a054-3eda-49b4-b390-7d5d16e30af811
308976carbamazepine 100 MG per 5 ML Oral SuspensionSY0526a054-3eda-49b4-b390-7d5d16e30af811
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY0526a054-3eda-49b4-b390-7d5d16e30af811
308976carbamazepine 200 MG per 10 ML Oral SuspensionSY0526a054-3eda-49b4-b390-7d5d16e30af811
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY0526a054-3eda-49b4-b390-7d5d16e30af811
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN1922a7cd-6a43-dab5-e063-6294a90a3d8f4
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD1922a7cd-6a43-dab5-e063-6294a90a3d8f4
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD1922a7cd-6a43-dab5-e063-6294a90a3d8f4
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD1922a7cd-6a43-dab5-e063-6294a90a3d8f4
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY1922a7cd-6a43-dab5-e063-6294a90a3d8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-4124-151672412401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-1) 2009-03-310000-00-00NoNoCurrent
51672-4124-3516724124031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-3) 2009-03-310000-00-00NoNoCurrent
51672-4124-65167241240630 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-6) 2009-03-310000-00-00NoNoCurrent