FDA.reportPublic FDA data

Carbamazepine

Product NDC
75834-221
11-digit product format
758340221
Labeler code
75834
Product ID
75834-221_45806c19-4811-987e-e063-6394a90aa8fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
NIVAGEN PHARMACEUTICALS, INC.
Application
ANDA207798
Marketing category
ANDA
Marketing start
2020-04-21
Substance
CARBAMAZEPINE
Active strength
200 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui197441, 308979

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
75834-221-00Carbamazepine1000 in 1 BOTTLETABLET100020
75834-221-01Carbamazepine100 in 1 BOTTLETABLET10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-221-00EA - Each75834-221b4462764-affe-48c8-bf37-779cae4d27a512020-06-05
75834-221-01EA - Each75834-221c425f8ed-ebf2-45f7-9acd-60a31e75ed0112020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-221CARBAMAZEPINE TABLET [NIVAGEN PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 2 package rows20241225_e68998cb-5f91-4d7e-85a6-555efb8b0384.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN62d38b93-7dd0-48e7-bd59-a434d52520f6105
308979carbamazepine 200 MG Oral TabletSCD62d38b93-7dd0-48e7-bd59-a434d52520f6105
197441carBAMazepine 100 MG Oral TabletPSNe68998cb-5f91-4d7e-85a6-555efb8b038420
308979carBAMazepine 200 MG Oral TabletPSNe68998cb-5f91-4d7e-85a6-555efb8b038420
197441carbamazepine 100 MG Oral TabletSCDe68998cb-5f91-4d7e-85a6-555efb8b038420
308979carbamazepine 200 MG Oral TabletSCDe68998cb-5f91-4d7e-85a6-555efb8b038420
308979carBAMazepine 200 MG Oral TabletPSN9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217
308979carbamazepine 200 MG Oral TabletSCD9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217
308979carBAMazepine 200 MG Oral TabletPSN047bc284-060a-4db9-bf37-75d10f95a0a67
308979carbamazepine 200 MG Oral TabletSCD047bc284-060a-4db9-bf37-75d10f95a0a67
308979carBAMazepine 200 MG Oral TabletPSN867a5f4d-8ae6-4339-bbb4-0bf62fb082e56
308979carbamazepine 200 MG Oral TabletSCD867a5f4d-8ae6-4339-bbb4-0bf62fb082e56
308979carBAMazepine 200 MG Oral TabletPSNb56dd9c8-1bca-21e3-e053-2995a90a3e6e2
308979carbamazepine 200 MG Oral TabletSCDb56dd9c8-1bca-21e3-e053-2995a90a3e6e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-221-00758340221001000 TABLET in 1 BOTTLE (75834-221-00) 1000 tablet2020-04-210000-00-00NoNoCurrent
75834-221-0175834022101100 TABLET in 1 BOTTLE (75834-221-01) 100 tablet2020-04-210000-00-00NoNoCurrent