Dexamethasone
Summary of product characteristics
Effective Time
20240330
Version
2
Spl Product Data Elements
Dexamethasone Dexamethasone DEXAMETHASONE DEXAMETHASONE FD&C BLUE NO. 1 ALUMINUM LAKE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SUCROSE off-white to light green 1736 Dexamethasone Dexamethasone DEXAMETHASONE DEXAMETHASONE FD&C BLUE NO. 1 ALUMINUM LAKE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SUCROSE off-white to light blue 1737 Dexamethasone Dexamethasone DEXAMETHASONE DEXAMETHASONE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SUCROSE light yellow to yellow 1791 Dexamethasone Dexamethasone DEXAMETHASONE DEXAMETHASONE FD&C BLUE NO. 1 ALUMINUM LAKE FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SUCROSE off-white to grey 1792 Dexamethasone Dexamethasone DEXAMETHASONE DEXAMETHASONE ALUMINUM OXIDE FD&C RED NO. 40 FERRIC OXIDE RED LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SUCROSE light-pink to pink 1795
Application Number
ANDA216282
Brand Name
Dexamethasone
Generic Name
Dexamethasone
Product Ndc
70771-1707
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1704-1 Dexamethasone Tablets, USP 0.5 mg 100 Tablets Rx only Zydus NDC 70771-1705-1 Dexamethasone Tablets, USP 0.75 mg 100 Tablets Rx only Zydus NDC 70771-1707-1 Dexamethasone Tablets, USP 1.5 mg 100 Tablets Rx only Zydus NDC 70771-1699-1 Dexamethasone Tablets, USP 4 mg 100 Tablets Rx only Zydus NDC 70771-1700-1 Dexamethasone Tablets, USP 6 mg 100 Tablets Rx only Zydus Dexamethasone tablets 0.5 mg Dexamethasone tablets 0.75 mg Dexamethasone tablets 1.5 mg Dexamethasone tablets 4 mg Dexamethasone tablets 6 mg
Spl Unclassified Section
SPL UNCLASSIFIED
150 mins
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