FDA.reportPublic FDA data

Carbamazepine

Product NDC
71610-336
11-digit product format
716100336
Labeler code
71610
Product ID
71610-336_41720bf1-61cb-4bc6-ac53-bda416af15fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074649
Marketing category
ANDA
Marketing start
1996-10-03
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
No
Listing certified through
2020-12-31
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
71610-336-302023-01-30C16284748780-1f386c64a-42d8-0266-e053-dadaa90a7c1aCarbamazepine Tablets USP, 200 mg
71610-336-532023-01-30C16284748780-1f386c64a-42d8-0266-e053-dadaa90a7c1aCarbamazepine Tablets USP, 200 mg
71610-336-602023-01-30C16284748780-1f386c64a-42d8-0266-e053-dadaa90a7c1aCarbamazepine Tablets USP, 200 mg
71610-336-802023-01-30C16284748780-1f386c64a-42d8-0266-e053-dadaa90a7c1aCarbamazepine Tablets USP, 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-336-30Carbamazepine30 in 1 BOTTLETABLET301
71610-336-53Carbamazepine60 in 1 BOTTLETABLET601
71610-336-60Carbamazepine90 in 1 BOTTLETABLET901
71610-336-80Carbamazepine180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-336-30EA - Each71610-336f5d848c3-2f7f-4e96-adbf-ec8a971583de12019-10-07
71610-336-53EA - Each71610-33636fac764-bfc4-4902-845d-e5f53a4f87eb12019-10-07
71610-336-60EA - Each71610-336ea4dc862-e3f4-4591-83b9-df67335f440d12019-10-07
71610-336-80EA - Each71610-336758eecb4-57ac-4a92-ae76-430ee267444e12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-336CARBAMAZEPINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20190831_41720bf1-61cb-4bc6-ac53-bda416af15fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN41720bf1-61cb-4bc6-ac53-bda416af15fc1
308979carbamazepine 200 MG Oral TabletSCD41720bf1-61cb-4bc6-ac53-bda416af15fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-336-307161003363030 TABLET in 1 BOTTLE (71610-336-30) 30 tablet2019-08-190000-00-00NoNoCurrent
71610-336-537161003365360 TABLET in 1 BOTTLE (71610-336-53) 60 tablet2019-08-150000-00-00NoNoCurrent
71610-336-607161003366090 TABLET in 1 BOTTLE (71610-336-60) 90 tablet2019-08-150000-00-00NoNoCurrent
71610-336-8071610033680180 TABLET in 1 BOTTLE (71610-336-80) 180 tablet2019-08-150000-00-00NoNoCurrent