FDA.reportPublic FDA data

Carbamazepine

Product NDC
70954-240
11-digit product format
709540240
Labeler code
70954
Product ID
70954-240_cd071fae-afb9-4b46-8e1c-dcb99d5c0f61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA214277
Marketing category
ANDA
Marketing start
2022-10-06
Substance
CARBAMAZEPINE
Active strength
100 mg/5mL
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
CARBAMAZEPINE100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308976

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
70954-240-10Carbamazepine1 in 1 CARTONSUSPENSION13
70954-240-10Carbamazepine450 mL in 1 BOTTLESUSPENSION4503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-240-10ML - Milliliter70954-2401b4b39df-b028-470b-8090-5ca2de10e03912022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-240CARBAMAZEPINE SUSPENSION [ANI PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20231118_e006049f-1c0c-4544-969e-0344d1b8c5ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSNe006049f-1c0c-4544-969e-0344d1b8c5ba3
308976carbamazepine 20 MG/ML Oral SuspensionSCDe006049f-1c0c-4544-969e-0344d1b8c5ba3
308976carbamazepine 100 MG per 5 ML Oral SuspensionSYe006049f-1c0c-4544-969e-0344d1b8c5ba3
308976carbamazepine 200 MG per 10 ML Oral SuspensionSYe006049f-1c0c-4544-969e-0344d1b8c5ba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-240-10709540240101 BOTTLE in 1 CARTON (70954-240-10) / 450 mL in 1 BOTTLE1 bottle2022-10-060000-00-00NoNoCurrent