Clonazepam

Product NDC
53217-189
11-digit product format
532170189
Labeler code
53217
Product ID
53217-189_0fbaaade-7d41-48a3-8ef2-ef824a321c2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA074979
Marketing category
ANDA
Marketing start
1997-08-29
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-189-02Clonazepam120 in 1 BOTTLETABLET1201
53217-189-30Clonazepam30 in 1 BOTTLETABLET301
53217-189-60Clonazepam60 in 1 BOTTLETABLET601
53217-189-90Clonazepam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-189-02EA - Each53217-1893e31ac50-ae03-48dc-8544-407ad61766d812017-03-06
53217-189-30EA - Each53217-1892d7afc0d-95ff-4996-8866-2965a879e0f412017-03-06
53217-189-60EA - Each53217-189ff570336-e0f0-48ae-9162-ee1b8550c3b212017-03-06
53217-189-90EA - Each53217-1893c95ae5e-37ad-4329-9e26-3c9f9db3df3712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-189CLONAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20170302_272f5bc7-23ec-4e33-af57-bb2b9b2b10cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN272f5bc7-23ec-4e33-af57-bb2b9b2b10cb1
197528clonazepam 1 MG Oral TabletSCD272f5bc7-23ec-4e33-af57-bb2b9b2b10cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-189-0253217018902120 in 1 BOTTLEHistorical
53217-189-305321701893030 in 1 BOTTLEHistorical
53217-189-605321701896060 in 1 BOTTLEHistorical
53217-189-905321701899090 in 1 BOTTLEHistorical