FDA.reportPublic FDA data

Clonazepam

Product NDC
33261-340
11-digit product format
332610340
Labeler code
33261
Product ID
33261-340_8fa29043-847f-4835-b929-70ac0e139880
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals 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
33261-340-302020-01-31C16284748780-19d75b9d0-49db-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
33261-340-452020-01-31C16284748780-19d75b9d0-49db-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
33261-340-602020-01-31C16284748780-19d75b9d0-49db-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
33261-340-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET301
33261-340-45Clonazepam45 in 1 BOTTLE, PLASTICTABLET451
33261-340-60Clonazepam60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-340-30EA - Each33261-340c8de362e-4507-41c5-8cc6-d85fc127651b12015-10-02
33261-340-60EA - Each33261-3407ca9d149-0305-4a2e-bcff-64eef20b08db12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-340CLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140106_487d4493-4526-472f-8dbc-8ae1b9fe40d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN487d4493-4526-472f-8dbc-8ae1b9fe40d01
197528clonazePAM 1 MG Oral TabletPSN487d4493-4526-472f-8dbc-8ae1b9fe40d01
197529clonazePAM 2 MG Oral TabletPSN487d4493-4526-472f-8dbc-8ae1b9fe40d01
197527clonazepam 0.5 MG Oral TabletSCD487d4493-4526-472f-8dbc-8ae1b9fe40d01
197528clonazepam 1 MG Oral TabletSCD487d4493-4526-472f-8dbc-8ae1b9fe40d01
197529clonazepam 2 MG Oral TabletSCD487d4493-4526-472f-8dbc-8ae1b9fe40d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-340-303326103403030 in 1 BOTTLE, PLASTICHistorical
33261-340-453326103404545 in 1 BOTTLE, PLASTICHistorical
33261-340-603326103406060 in 1 BOTTLE, PLASTICHistorical