FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
17856-0029
11-digit product format
178560029
Labeler code
17856
Product ID
17856-0029_8fe5545e-d942-4062-bb81-7b554b58ef6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA075714
Marketing category
ANDA
Marketing start
2002-06-05
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0029-12024-01-30C16284748780-1d6a99b39-bcd0-a426-e053-dadaa90af4c2CARBAMAZEPINE - carbamazepine suspension Morton Grove Pharmaceuticals, Inc. Rx only
17856-0029-12022-09-26C16284748780-1d6a99b39-bcd0-a426-e053-dadaa90af4c2CARBAMAZEPINE - carbamazepine suspension Morton Grove Pharmaceuticals, Inc. Rx only
17856-0029-12022-01-28C16284748780-1d6a99b39-bcd0-a426-e053-dadaa90af4c2CARBAMAZEPINE - carbamazepine suspension Morton Grove Pharmaceuticals, Inc. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0029-1CARBAMAZEPINE72 in 1 BOX, UNIT-DOSESUSPENSION722
17856-0029-2CARBAMAZEPINE10 mL in 1 CUP, UNIT-DOSESUSPENSION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0029CARBAMAZEPINE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 2 package rows20220927_364aa931-f090-406b-8e79-c44e7592520e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSN364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 20 MG/ML Oral SuspensionSCD364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 100 MG per 5 ML Oral SuspensionSY364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 200 MG per 10 ML Oral SuspensionSY364aa931-f090-406b-8e79-c44e7592520e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0029-11785600290172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0029-1) > 10 mL in 1 CUP, UNIT-DOSE2020-04-100000-00-00NoNoCurrent
17856-0029-21785600290210 mL in 1 CUP, UNIT-DOSE10 mlHistorical