Estazolam

Product NDC
21695-220
11-digit product format
216950220
Labeler code
21695
Product ID
21695-220_3607bed9-64f3-4b14-9b4d-7cc70dc8b185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estazolam
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074818
Marketing category
ANDA
Marketing start
1997-08-19
Marketing end
0000-00-00
Substance
ESTAZOLAM
Active strength
2 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
c28edef2-84bd-a44a-8c21-ece06e730fcfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-220-302019-09-24C16284748780-1934fe258-4d22-48b1-e053-8cdaa90a720aEstazolam Tablets CIV Revised: September 2008 Rx only 14444-2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-220-30Estazolam30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-220-30EA - Each21695-220225553ab-1360-442a-9f03-1c9f243cbc6e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTAZOLAMACTIVE INGREDIENT36S3EQV54CESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
ESTAZOLAMACTIVE MOIETY36S3EQV54CESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-220ESTAZOLAM TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110622_3607bed9-64f3-4b14-9b4d-7cc70dc8b185.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197654estazolam 2 MG Oral TabletPSN3607bed9-64f3-4b14-9b4d-7cc70dc8b1851
197654estazolam 2 MG Oral TabletSCD3607bed9-64f3-4b14-9b4d-7cc70dc8b1851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-220-302169502203030 in 1 BOTTLE, PLASTICHistorical