Clonazepam

Product NDC
52959-630
11-digit product format
529590630
Labeler code
52959
Product ID
52959-630_8a441358-7fed-46d1-9401-ba50193cc639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA074869
Marketing category
ANDA
Marketing start
2009-02-13
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-630-00Clonazepam100 in 1 BOTTLETABLET1001
52959-630-02Clonazepam120 in 1 BOTTLETABLET1201
52959-630-18Clonazepam180 in 1 BOTTLETABLET1801
52959-630-30Clonazepam30 in 1 BOTTLETABLET301
52959-630-60Clonazepam60 in 1 BOTTLETABLET601
52959-630-90Clonazepam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-630-00EA - Each52959-6304db8f9f8-2e2f-4727-91b8-d6809ec59b8112012-07-24
52959-630-02EA - Each52959-630a4d1cd50-fd4c-45ff-8285-9e180694daa012012-07-24
52959-630-18EA - Each52959-63023683a96-5cc6-4510-a4dd-1172bcf77e4c12012-07-24
52959-630-30EA - Each52959-630cdd3071f-1e20-410c-a5a8-184dbebc034c12012-07-24
52959-630-60EA - Each52959-63098ea8736-8110-4b19-99f9-200d0db6975312012-07-24
52959-630-90EA - Each52959-6308eb258b5-0996-48bc-a7a5-1b3d3213c52c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONAZEPAMACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
CLONAZEPAMACTIVE MOIETY5PE9FDE8GBCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-630CLONAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 6 package rows20111215_ec0e596c-baca-417d-8aa4-a1878100064d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSNec0e596c-baca-417d-8aa4-a1878100064d1
197528clonazePAM 1 MG Oral TabletPSNec0e596c-baca-417d-8aa4-a1878100064d1
197529clonazePAM 2 MG Oral TabletPSNec0e596c-baca-417d-8aa4-a1878100064d1
197527clonazepam 0.5 MG Oral TabletSCDec0e596c-baca-417d-8aa4-a1878100064d1
197528clonazepam 1 MG Oral TabletSCDec0e596c-baca-417d-8aa4-a1878100064d1
197529clonazepam 2 MG Oral TabletSCDec0e596c-baca-417d-8aa4-a1878100064d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-630-0052959063000100 in 1 BOTTLEHistorical
52959-630-0252959063002120 in 1 BOTTLEHistorical
52959-630-1852959063018180 in 1 BOTTLEHistorical
52959-630-305295906303030 in 1 BOTTLEHistorical
52959-630-605295906306060 in 1 BOTTLEHistorical
52959-630-905295906309090 in 1 BOTTLEHistorical