FDA.reportPublic FDA data

Carbamazepine

Product NDC
17856-4047
11-digit product format
178564047
Labeler code
17856
Product ID
17856-4047_30a4fdec-3fbc-034c-e063-6294a90aa786
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA076729
Marketing category
ANDA
Marketing start
2004-09-20
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
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-4047-12025-03-18C16284748780-19d75b9d0-fc46-f424-e053-dadaa90a57ceCarbamazepine Oral Suspension USP, 100 mg/5 mL
17856-4047-12020-01-31C16284748780-19d75b9d0-fc46-f424-e053-dadaa90a57ceCarbamazepine Oral Suspension USP, 100 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-4047-1Carbamazepine10 mL in 1 CUPSUSPENSION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-4047-1ML - Milliliter17856-404724e9919b-019d-40b5-aa74-48bd29bddd6d12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-4047CARBAMAZEPINE SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3Current NDC, Legacy NDC, 1 package rows20250321_25939406-a836-43cd-9301-56808e9b31ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSN25939406-a836-43cd-9301-56808e9b31ec3
308976carbamazepine 20 MG/ML Oral SuspensionSCD25939406-a836-43cd-9301-56808e9b31ec3
308976carbamazepine 100 MG per 5 ML Oral SuspensionSY25939406-a836-43cd-9301-56808e9b31ec3
308976carbamazepine 200 MG per 10 ML Oral SuspensionSY25939406-a836-43cd-9301-56808e9b31ec3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-4047-11785640470110 mL in 1 CUP (17856-4047-1) 10 ml2015-04-28NoNoCurrent