Estazolam

Product NDC
75907-028
11-digit product format
759070028
Labeler code
75907
Product ID
75907-028_72da6d6d-2d81-d7a4-6454-2b8967981fea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estazolam
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Labratories Inc.
Application
ANDA074921
Marketing category
ANDA
Marketing start
2024-02-15
Substance
ESTAZOLAM
Active strength
1 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
ESTAZOLAM1 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
75907-028-01Estazolam100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-028-01EA - Each75907-0285b89a3c3-8ed6-4314-a401-0a1a899e512a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-028ESTAZOLAM TABLET [DR. REDDY'S LABRATORIES INC.]1Current NDC, 1 package rows20240215_2f349a44-6d04-01d1-c8b7-12254aead77d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197653estazolam 1 MG Oral TabletPSN2f349a44-6d04-01d1-c8b7-12254aead77d1
197654estazolam 2 MG Oral TabletPSN2f349a44-6d04-01d1-c8b7-12254aead77d1
197653estazolam 1 MG Oral TabletSCD2f349a44-6d04-01d1-c8b7-12254aead77d1
197654estazolam 2 MG Oral TabletSCD2f349a44-6d04-01d1-c8b7-12254aead77d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-028-0175907002801100 TABLET in 1 BOTTLE, PLASTIC (75907-028-01) 100 tablet2024-02-15NoNoCurrent