FDA.reportPublic FDA data

Carbamazepine

Product NDC
53808-0915
11-digit product format
538080915
Labeler code
53808
Product ID
53808-0915_18def499-cbff-49a0-bdf7-dd5d38fc6f01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA075948
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0915-12021-01-29C16284748780-1956f9ecf-d377-621f-e053-dbdaa90a74adCARBAMAZEPINE TABLETS, USP
53808-0915-12019-10-21C16284748780-1956f9ecf-d377-621f-e053-dbdaa90a74adCARBAMAZEPINE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0915-1Carbamazepine30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0915CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100806_6903e7ef-8b5c-4b64-a87d-62f1f102bc75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197441carBAMazepine 100 MG Oral TabletPSN6903e7ef-8b5c-4b64-a87d-62f1f102bc751
308979carBAMazepine 200 MG Oral TabletPSN6903e7ef-8b5c-4b64-a87d-62f1f102bc751
197441carbamazepine 100 MG Oral TabletSCD6903e7ef-8b5c-4b64-a87d-62f1f102bc751
308979carbamazepine 200 MG Oral TabletSCD6903e7ef-8b5c-4b64-a87d-62f1f102bc751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0915-15380809150130 in 1 BLISTER PACKHistorical