FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
69452-312
11-digit product format
694520312
Labeler code
69452
Product ID
69452-312_4527dbc6-0c73-9bef-e063-6294a90acf8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.,
Application
ANDA218221
Marketing category
ANDA
Marketing start
2024-03-15
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
CARBAMAZEPINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308979

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
69452-312-20CARBAMAZEPINE100 in 1 BOTTLETABLET1004
69452-312-32CARBAMAZEPINE1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-312-20EA - Each69452-3125e3189d6-a5a1-475e-adda-07afcbe8eaf712024-06-10
69452-312-32EA - Each69452-31213728696-bb87-49a5-bd00-ae475598ee4a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-312CARBAMAZEPINE TABLET [BIONPHARMA INC.,]3Current NDC, 2 package rows20250322_138d9ed1-2f8e-d19d-e063-6394a90a695d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN138d9ed1-2f8e-d19d-e063-6394a90a695d4
308979carBAMazepine 200 MG Oral TabletPSN5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c4
308979carbamazepine 200 MG Oral TabletSCD138d9ed1-2f8e-d19d-e063-6394a90a695d4
308979carbamazepine 200 MG Oral TabletSCD5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c4
308979carBAMazepine 200 MG Oral TabletPSN41157f3e-61c4-1cbd-e063-6294a90a219f1
308979carbamazepine 200 MG Oral TabletSCD41157f3e-61c4-1cbd-e063-6294a90a219f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-312-2069452031220100 TABLET in 1 BOTTLE (69452-312-20) 100 tablet2024-03-15NoNoCurrent
69452-312-32694520312321000 TABLET in 1 BOTTLE (69452-312-32) 1000 tablet2024-07-15NoNoCurrent