Dexamethasone

DEXAMETHASONE- dexamethasone tablet
Zydus Lifesciences Limited

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1704-1

Dexamethasone Tablets, USP 0.5 mg

100 Tablets

Rx only

Zydus

Dexamethasone tablets 0.5 mg
(click image for full-size original)

NDC 70771-1705-1

Dexamethasone Tablets, USP 0.75 mg

100 Tablets

Rx only

Zydus

Dexamethasone tablets 0.75 mg
(click image for full-size original)

NDC 70771-1707-1

Dexamethasone Tablets, USP 1.5 mg

100 Tablets

Rx only

Zydus

Dexamethasone tablets 1.5 mg
(click image for full-size original)

NDC 70771-1699-1

Dexamethasone Tablets, USP 4 mg

100 Tablets

Rx only

Zydus

Dexamethasone tablets 4 mg
(click image for full-size original)

NDC 70771-1700-1

Dexamethasone Tablets, USP 6 mg

100 Tablets

Rx only

Zydus

Dexamethasone tablets 6 mg
(click image for full-size original)
DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1699
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 4 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 ALUMINUM LAKE
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
Product Characteristics
Color GREEN (off-white to light green) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 1736
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1699-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216282 03/18/2024
DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1700
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 6 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 ALUMINUM LAKE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
Product Characteristics
Color BLUE (off-white to light blue) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 1737
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1700-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216282 03/18/2024
DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1704
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
Product Characteristics
Color YELLOW (light yellow to yellow) Score 2 pieces
Shape OVAL Size 6mm
Flavor Imprint Code 1791
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1704-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216282 03/18/2024
DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1705
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 0.75 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 ALUMINUM LAKE
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
Product Characteristics
Color GRAY (off-white to grey) Score 2 pieces
Shape OVAL Size 7mm
Flavor Imprint Code 1792
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1705-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216282 03/18/2024
DEXAMETHASONE
dexamethasone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1707
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1.5 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
FD&C RED NO. 40
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SUCROSE
Product Characteristics
Color PINK (light-pink to pink) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 1795
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1707-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216282 03/18/2024
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 677605858 ANALYSIS (70771-1704), ANALYSIS (70771-1705), ANALYSIS (70771-1707), ANALYSIS (70771-1699), ANALYSIS (70771-1700), MANUFACTURE (70771-1704), MANUFACTURE (70771-1705), MANUFACTURE (70771-1707), MANUFACTURE (70771-1699), MANUFACTURE (70771-1700)

Revised: 02/2024 Zydus Lifesciences Limited

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