FDA.reportPublic FDA data

Estazolam

Product NDC
0591-0745
11-digit product format
005910745
Labeler code
0591
Product ID
0591-0745_5189e5a6-f58a-4eab-ac95-9d8011d6f3db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estazolam
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074818
Marketing category
ANDA
Marketing start
1997-10-01
Substance
ESTAZOLAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Estazolam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTAZOLAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36S3EQV54C
Rxcui197653, 197654

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c28edef2-84bd-a44a-8c21-ece06e730fcfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0745-01Estazolam100 in 1 BOTTLE, PLASTICTABLET10023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0745-01EA - Each0591-07456ca3e78e-da68-47e2-a674-1bbb58f3d3a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTAZOLAMACTIVE INGREDIENT36S3EQV54CESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
ESTAZOLAMACTIVE MOIETY36S3EQV54CESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APESTAZOLAM TABLET [WATSON LABORATORIES, INC.]6
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
0591-0745ESTAZOLAM TABLET [ACTAVIS PHARMA, INC.]22Current NDC, Legacy NDC, 1 package rows20230125_a1e3b4bf-22e9-430a-a768-4d86ae886c9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197653estazolam 1 MG Oral TabletPSNa1e3b4bf-22e9-430a-a768-4d86ae886c9e23
197654estazolam 2 MG Oral TabletPSNa1e3b4bf-22e9-430a-a768-4d86ae886c9e23
197653estazolam 1 MG Oral TabletSCDa1e3b4bf-22e9-430a-a768-4d86ae886c9e23
197654estazolam 2 MG Oral TabletSCDa1e3b4bf-22e9-430a-a768-4d86ae886c9e23
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0745-0100591074501100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01) 100 tablet1997-10-010000-00-00NoNoCurrent