FDA.reportPublic FDA data

Clonazepam

Product NDC
67544-289
11-digit product format
675440289
Labeler code
67544
Product ID
67544-289_382275d5-742c-4156-942f-2fb4810c6e68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074869
Marketing category
ANDA
Marketing start
2009-02-13
Marketing end
2020-06-30
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-289-15Clonazepam15 in 1 BOTTLE, PLASTICTABLET153
67544-289-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET303
67544-289-31Clonazepam31 in 1 BOTTLE, PLASTICTABLET313
67544-289-45Clonazepam45 in 1 BOTTLE, PLASTICTABLET453
67544-289-46Clonazepam56 in 1 BOTTLE, PLASTICTABLET563
67544-289-53Clonazepam60 in 1 BOTTLE, PLASTICTABLET603
67544-289-55Clonazepam75 in 1 BOTTLE, PLASTICTABLET753
67544-289-60Clonazepam90 in 1 BOTTLE, PLASTICTABLET903
67544-289-70Clonazepam120 in 1 BOTTLE, PLASTICTABLET1203
67544-289-75Clonazepam150 in 1 BOTTLE, PLASTICTABLET1503
67544-289-80Clonazepam180 in 1 BOTTLE, PLASTICTABLET1803
67544-289-90Clonazepam240 in 1 BOTTLE, PLASTICTABLET2403
67544-289-92Clonazepam270 in 1 BOTTLE, PLASTICTABLET2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-289-15EA - Each67544-289701f2fc4-6a29-4e56-ab84-64c49c6eef4912013-06-04
67544-289-30EA - Each67544-289caa553e8-2304-48b6-b973-bb0145d60ebf12013-06-04
67544-289-45EA - Each67544-28934d936e3-1925-4926-9bd0-fcb6edd2eefd12013-06-04
67544-289-46EA - Each67544-289c26c8319-65cd-457d-b7fa-fcbcb5258b8c12013-07-02
67544-289-53EA - Each67544-28946350b49-7fcb-439a-a925-b4080142844c12013-06-04
67544-289-55EA - Each67544-2896968fc15-5990-4235-b314-e873e9151a6412013-06-04
67544-289-60EA - Each67544-28915e64e66-3fe9-4995-b331-5d1a59f2bfe312013-06-04
67544-289-70EA - Each67544-289935aa2f8-3072-4a11-9acf-697faef1b26e12013-06-04
67544-289-75EA - Each67544-289b6b919ec-482b-478e-b3fe-a57bdc4dc00412014-04-03
67544-289-80EA - Each67544-28936082069-2f32-4692-ac2f-afad5a2baf4612013-06-04
67544-289-90EA - Each67544-28970e6f3ab-1f39-4817-b410-81631804e66112014-04-03
67544-289-92EA - Each67544-28902cb5a68-2c85-4fa2-991f-9b2ebdb02c3712014-04-03

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
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONAZEPAM 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
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-289CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 13 package rows20191227_a2bc95cc-a716-44f3-b6fe-c7874aa6606f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSNa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197528clonazePAM 1 MG Oral TabletPSNa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197529clonazePAM 2 MG Oral TabletPSNa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197527clonazepam 0.5 MG Oral TabletSCDa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197528clonazepam 1 MG Oral TabletSCDa2bc95cc-a716-44f3-b6fe-c7874aa6606f3
197529clonazepam 2 MG Oral TabletSCDa2bc95cc-a716-44f3-b6fe-c7874aa6606f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-289-156754402891515 in 1 BOTTLE, PLASTICHistorical
67544-289-306754402893030 in 1 BOTTLE, PLASTICHistorical
67544-289-316754402893131 in 1 BOTTLE, PLASTICHistorical
67544-289-456754402894545 in 1 BOTTLE, PLASTICHistorical
67544-289-466754402894656 in 1 BOTTLE, PLASTICHistorical
67544-289-536754402895360 in 1 BOTTLE, PLASTICHistorical
67544-289-556754402895575 in 1 BOTTLE, PLASTICHistorical
67544-289-606754402896090 in 1 BOTTLE, PLASTICHistorical
67544-289-7067544028970120 in 1 BOTTLE, PLASTICHistorical
67544-289-7567544028975150 in 1 BOTTLE, PLASTICHistorical
67544-289-8067544028980180 in 1 BOTTLE, PLASTICHistorical
67544-289-9067544028990240 in 1 BOTTLE, PLASTICHistorical
67544-289-9267544028992270 in 1 BOTTLE, PLASTICHistorical