Estazolam
ESTAZOLAM TABLETS CIV
Approved
Approval ID
9aaffc1b-3779-4e6f-89ed-fb302ecd1807
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
Mayne Pharma
DUNS: 867220261
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Estazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51862-073
Application NumberANDA074921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estazolam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (4)
EstazolamActive
Quantity: 1 mg in 1 1
Code: 36S3EQV54C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Estazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51862-074
Application NumberANDA074921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estazolam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2022
FDA Product Classification
INGREDIENTS (6)
EstazolamActive
Quantity: 2 mg in 1 1
Code: 36S3EQV54C
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/23/2022
PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label
NDC 51862-074-01
Estazolam
Tablets
CIV
2 mg
PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.
Rx Only
100 Tablets
maynepharma
