FDA.reportPublic FDA data

Clonazepam

Product NDC
67544-697
11-digit product format
675440697
Labeler code
67544
Product ID
67544-697_37c91b72-c47b-4200-a66a-2f3a24de2e43
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
67544-697-152020-01-31C16284748780-19d75b9cf-f74f-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
67544-697-302020-01-31C16284748780-19d75b9cf-f74f-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
67544-697-452020-01-31C16284748780-19d75b9cf-f74f-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
67544-697-532020-01-31C16284748780-19d75b9cf-f74f-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
67544-697-602020-01-31C16284748780-19d75b9cf-f74f-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
67544-697-702020-01-31C16284748780-19d75b9cf-f74f-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
67544-697-752020-01-31C16284748780-19d75b9cf-f74f-f424-e053-dadaa90a57ceCLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only
67544-697-802020-01-31C16284748780-19d75b9cf-f74f-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
67544-697-15Clonazepam15 in 1 BOTTLE, PLASTICTABLET152
67544-697-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET302
67544-697-45Clonazepam45 in 1 BOTTLE, PLASTICTABLET452
67544-697-53Clonazepam60 in 1 BOTTLE, PLASTICTABLET602
67544-697-60Clonazepam90 in 1 BOTTLE, PLASTICTABLET902
67544-697-70Clonazepam120 in 1 BOTTLE, PLASTICTABLET1202
67544-697-75Clonazepam150 in 1 BOTTLE, PLASTICTABLET1502
67544-697-80Clonazepam180 in 1 BOTTLE, PLASTICTABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-697-15EA - Each67544-69730460f69-464b-4171-96a8-84ff0bda136b12014-05-02
67544-697-30EA - Each67544-697f87d1d4e-759b-4f1d-b2b8-bffc94ff753a12014-05-02
67544-697-45EA - Each67544-697595ce7b8-4755-4424-a156-97e53a20895c12014-05-02
67544-697-53EA - Each67544-6979b0d1ed8-0629-400b-94ca-52f2747e647512014-05-02
67544-697-60EA - Each67544-6970956f319-0583-4287-b406-d321313f04aa12014-05-02
67544-697-70EA - Each67544-697d1ac88fe-a173-4a84-90a4-38feeff5423812014-05-02
67544-697-75EA - Each67544-69755a96b25-6c2a-425f-a126-a89504b7cd5e12014-05-02
67544-697-80EA - Each67544-697b300457c-a8e6-48e8-a00e-02b3e1e2e52712014-05-02

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
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
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-697CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 8 package rows20140422_31e46c66-18ad-4510-a4ca-a8b3878841d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN31e46c66-18ad-4510-a4ca-a8b3878841d32
197527clonazepam 0.5 MG Oral TabletSCD31e46c66-18ad-4510-a4ca-a8b3878841d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-697-156754406971515 in 1 BOTTLE, PLASTICHistorical
67544-697-306754406973030 in 1 BOTTLE, PLASTICHistorical
67544-697-456754406974545 in 1 BOTTLE, PLASTICHistorical
67544-697-536754406975360 in 1 BOTTLE, PLASTICHistorical
67544-697-606754406976090 in 1 BOTTLE, PLASTICHistorical
67544-697-7067544069770120 in 1 BOTTLE, PLASTICHistorical
67544-697-7567544069775150 in 1 BOTTLE, PLASTICHistorical
67544-697-8067544069780180 in 1 BOTTLE, PLASTICHistorical