FDA.reportPublic FDA data

Tegretol

Product NDC
0078-0509
11-digit product format
000780509
Labeler code
0078
Product ID
0078-0509_2765f762-2f4e-4a2b-ac10-cf8149d9a38e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA016608
Marketing category
NDA
Marketing start
1968-03-11
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
Tegretol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui199378, 308971, 308972, 308976, 308979, 402505, 402506, 866303, 866305, 866307

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
0078-0509-05Tegretol100 in 1 BOTTLETABLET10036
0078-0509-20Tegretol60 in 1 BOTTLETABLET6036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0509-05EA - Each0078-0509c2102e0f-b9bc-476b-8afe-3fb16fd9c21712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
CARBAMAZEPINEACTIVE MOIETY33CM23913MTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
DEXTRATESINACTIVE INGREDIENTG263MI44RUTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
GELATININACTIVE INGREDIENT2G86QN327LTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
MANNITOLINACTIVE INGREDIENT3OWL53L36ATEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
SORBITOLINACTIVE INGREDIENT506T60A25RTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
SUCROSEINACTIVE INGREDIENTC151H8M554TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
WATERINACTIVE INGREDIENT059QF0KO0RTEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0509TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]34Current NDC, Legacy NDC, 2 package rows20250122_8d409411-aa9f-4f3a-a52c-fbcb0c3ec053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308979carBAMazepine 200 MG Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308971Tegretol 100 MG in 5 mL Oral SuspensionPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308972Tegretol 200 MG Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
866303Tegretol XR 100 MG 12HR Extended Release Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
866305Tegretol XR 200 MG 12HR Extended Release Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
866307Tegretol XR 400 MG 12HR Extended Release Oral TabletPSN8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
86630312 HR carbamazepine 100 MG Extended Release Oral Tablet [Tegretol]SBD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
86630512 HR carbamazepine 200 MG Extended Release Oral Tablet [Tegretol]SBD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
86630712 HR carbamazepine 400 MG Extended Release Oral Tablet [Tegretol]SBD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308971carbamazepine 20 MG/ML Oral Suspension [Tegretol]SBD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308972carbamazepine 200 MG Oral Tablet [Tegretol]SBD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308976carbamazepine 20 MG/ML Oral SuspensionSCD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308979carbamazepine 200 MG Oral TabletSCD8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
86630312 HR Tegretol XR 100 MG Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
86630512 HR Tegretol XR 200 MG Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
86630712 HR Tegretol XR 400 MG Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308976carbamazepine 100 MG per 5 ML Oral SuspensionSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308976carbamazepine 200 MG per 10 ML Oral SuspensionSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308971Tegretol 100 MG per 5 ML Oral SuspensionSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308971Tegretol 20 MG/ML Oral SuspensionSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
308972Tegretol 200 MG Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
866303Tegretol XR 100 MG 12 HR Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
866305Tegretol XR 200 MG 12 HR Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336
866307Tegretol XR 400 MG 12 HR Extended Release Oral TabletSY8d409411-aa9f-4f3a-a52c-fbcb0c3ec05336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0509-0500078050905100 TABLET in 1 BOTTLE (0078-0509-05) 100 tablet1968-03-110000-00-00NoNoCurrent
0078-0509-200007805092060 TABLET in 1 BOTTLE (0078-0509-20) 60 tablet2017-04-060000-00-00NoNoCurrent