FDA.reportPublic FDA data

Clonazepam

Product NDC
43353-277
11-digit product format
433530277
Labeler code
43353
Product ID
43353-277_12b95e60-10f9-423f-9838-b2f514637f39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077856
Marketing category
ANDA
Marketing start
2006-06-28
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-277-152020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-302020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-452020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-462020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-532020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-552020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-602020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-702020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-752020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-802020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
43353-277-922020-01-31C16284748780-19d75b9d0-ff6d-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-277-15Clonazepam15 in 1 BOTTLE, PLASTICTABLET152
43353-277-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET302
43353-277-45Clonazepam45 in 1 BOTTLE, PLASTICTABLET452
43353-277-46Clonazepam56 in 1 BOTTLE, PLASTICTABLET562
43353-277-53Clonazepam60 in 1 BOTTLE, PLASTICTABLET602
43353-277-55Clonazepam75 in 1 BOTTLE, PLASTICTABLET752
43353-277-60Clonazepam90 in 1 BOTTLE, PLASTICTABLET902
43353-277-70Clonazepam120 in 1 BOTTLE, PLASTICTABLET1202
43353-277-75Clonazepam150 in 1 BOTTLE, PLASTICTABLET1502
43353-277-80Clonazepam180 in 1 BOTTLE, PLASTICTABLET1802
43353-277-92Clonazepam270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-277-30EA - Each43353-277e47bfdaa-67ab-4b14-b935-13d88f732dc512014-05-02
43353-277-46EA - Each43353-277ec5d6f6c-82d9-469f-bdec-5cc15d3a192f12014-05-02
43353-277-55EA - Each43353-27740162f35-fe00-4cf1-b104-fc381711838712014-05-02
43353-277-75EA - Each43353-2771b388aac-9bcd-4a39-9144-2ff5c9aefb6a12014-05-02
43353-277-80EA - Each43353-277bdec30b0-d5fa-4077-960b-1a427692ace812014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-277CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 11 package rows20140422_f868dfce-6ef4-4e08-89b1-2e4018ecd9c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSNf868dfce-6ef4-4e08-89b1-2e4018ecd9c52
197529clonazePAM 2 MG Oral TabletPSNf868dfce-6ef4-4e08-89b1-2e4018ecd9c52
197528clonazepam 1 MG Oral TabletSCDf868dfce-6ef4-4e08-89b1-2e4018ecd9c52
197529clonazepam 2 MG Oral TabletSCDf868dfce-6ef4-4e08-89b1-2e4018ecd9c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-277-154335302771515 in 1 BOTTLE, PLASTICHistorical
43353-277-304335302773030 in 1 BOTTLE, PLASTICHistorical
43353-277-454335302774545 in 1 BOTTLE, PLASTICHistorical
43353-277-464335302774656 in 1 BOTTLE, PLASTICHistorical
43353-277-534335302775360 in 1 BOTTLE, PLASTICHistorical
43353-277-554335302775575 in 1 BOTTLE, PLASTICHistorical
43353-277-604335302776090 in 1 BOTTLE, PLASTICHistorical
43353-277-7043353027770120 in 1 BOTTLE, PLASTICHistorical
43353-277-7543353027775150 in 1 BOTTLE, PLASTICHistorical
43353-277-8043353027780180 in 1 BOTTLE, PLASTICHistorical
43353-277-9243353027792270 in 1 BOTTLE, PLASTICHistorical