FDA.reportPublic FDA data

Carbamazepine

Product NDC
29033-019
11-digit product format
290330019
Labeler code
29033
Product ID
29033-019_9fcd6487-e123-44ca-a48f-3aa2e5858979
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Nostrum Laboratories, Inc.
Application
ANDA076697
Marketing category
ANDA
Marketing start
2020-02-17
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 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
2021-12-31
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
29033-019-122026-01-29C16284748780-149896155-ba75-586f-e063-e6dba90add90Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29033-019-12Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29033-019-12EA - Each29033-01973ff2f62-113e-4009-aa1b-c26ff4def38c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
ETHYLCELLULOSE (20 MPA.S)INACTIVE INGREDIENTBJG0S321QYCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29033-019CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]10Legacy NDC, 1 package rows20240216_fbca2152-0022-47a5-a1ea-58950b45bcbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNfbca2152-0022-47a5-a1ea-58950b45bcbf10
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNfbca2152-0022-47a5-a1ea-58950b45bcbf10
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNfbca2152-0022-47a5-a1ea-58950b45bcbf10
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDfbca2152-0022-47a5-a1ea-58950b45bcbf10
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDfbca2152-0022-47a5-a1ea-58950b45bcbf10
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDfbca2152-0022-47a5-a1ea-58950b45bcbf10
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYfbca2152-0022-47a5-a1ea-58950b45bcbf10
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYfbca2152-0022-47a5-a1ea-58950b45bcbf10
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYfbca2152-0022-47a5-a1ea-58950b45bcbf10
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSN33ed4e35-8be2-d0ea-e063-6394a90a06a61
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCD33ed4e35-8be2-d0ea-e063-6394a90a06a61
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSY33ed4e35-8be2-d0ea-e063-6394a90a06a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29033-019-1229033001912120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-019-12) 2020-02-170000-00-00NoNoCurrent