FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
16571-682
11-digit product format
165710682
Labeler code
16571
Product ID
16571-682_481f1ce3-177a-420c-822a-5fe0119a604f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA211623
Marketing category
ANDA
Marketing start
2020-04-24
Substance
CARBAMAZEPINE
Active strength
400 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M

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
16571-682-01CARBAMAZEPINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-682CARBAMAZEPINE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 1 package rows20250410_bf1590a0-68a7-45ed-817e-f97366f96ec4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSNbf1590a0-68a7-45ed-817e-f97366f96ec45
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSNbf1590a0-68a7-45ed-817e-f97366f96ec45
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSNbf1590a0-68a7-45ed-817e-f97366f96ec45
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCDbf1590a0-68a7-45ed-817e-f97366f96ec45
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCDbf1590a0-68a7-45ed-817e-f97366f96ec45
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCDbf1590a0-68a7-45ed-817e-f97366f96ec45
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSYbf1590a0-68a7-45ed-817e-f97366f96ec45
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSYbf1590a0-68a7-45ed-817e-f97366f96ec45
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSYbf1590a0-68a7-45ed-817e-f97366f96ec45
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN7108d630-89bc-4815-b6fb-a1f4676c496e3
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN7108d630-89bc-4815-b6fb-a1f4676c496e3
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD7108d630-89bc-4815-b6fb-a1f4676c496e3
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD7108d630-89bc-4815-b6fb-a1f4676c496e3
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY7108d630-89bc-4815-b6fb-a1f4676c496e3
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY7108d630-89bc-4815-b6fb-a1f4676c496e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-682-0116571068201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-682-01) 2020-04-240000-00-00NoNoCurrent