Carbamazepine

Product NDC
70518-2841
11-digit product format
705182841
Labeler code
70518
Product ID
70518-2841_50acf39d-5e31-9cd7-e063-6294a90a6de6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207798
Marketing category
ANDA
Marketing start
2020-08-19
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
2027-12-31
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
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308979

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
70518-2841-0Carbamazepine30 in 1 BLISTER PACKTABLET3017
70518-2841-1Carbamazepine100 in 1 BOXTABLET10017
70518-2841-2Carbamazepine1 in 1 POUCHTABLET117
70518-2841-3Carbamazepine30 in 1 BLISTER PACKTABLET3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2841-1EA - Each70518-28415bf9d7eb-8b29-4dfa-8fbc-5b072758781712026-02-05
70518-2841-2EA - Each70518-2841ade11306-436f-4315-84d8-f6b3fd3ed96a12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2841CARBAMAZEPINE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250501_9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217
308979carbamazepine 200 MG Oral TabletSCD9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2841-07051828410030 TABLET in 1 BLISTER PACK (70518-2841-0) 30 tablet2020-08-190000-00-00NoNoCurrent
70518-2841-170518284101100 POUCH in 1 BOX (70518-2841-1) / 1 TABLET in 1 POUCH (70518-2841-2) 100 pouch2022-02-080000-00-00NoNoCurrent
70518-2841-2705182841021 in 1 POUCHHistorical
70518-2841-37051828410330 TABLET in 1 BLISTER PACK (70518-2841-3) 30 tablet2021-08-090000-00-00NoNoCurrent