DEXAMETHASONE SODIUM PHOSPHATE

Product NDC
52584-238
11-digit product format
525840238
Labeler code
52584
Product ID
52584-238_1dde8e4c-c4ee-47a0-9e77-66b79ab57fb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone sodium phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE
Labeler
General Injectables & Vaccines, Inc.
Application
ANDA206781
Marketing category
ANDA
Marketing start
2019-09-06
Marketing end
0000-00-00
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
4 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-238-05525840238051 VIAL, MULTI-DOSE in 1 BAG (52584-238-05) > 5 mL in 1 VIAL, MULTI-DOSE2019-09-060000-00-00NoNoCurrent