Dexamethasone

Product NDC
71335-2405
11-digit product format
713352405
Labeler code
71335
Product ID
71335-2405_2b25f3c5-1372-4e07-aaaf-55e6fca3c689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215604
Marketing category
ANDA
Marketing start
2023-10-09
Substance
DEXAMETHASONE
Active strength
.75 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data

Finished product
Yes
Brand name base
Dexamethasone
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
DEXAMETHASONE.75 mg/1

Harmonized Identifiers

FieldValues
Unii7S5I7G3JQL
Rxcui343033

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7S5I7G3JQLDEXAMETHASONE50-02-2DEXAMETHASONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2405-17133524050112 TABLET in 1 BOTTLE (71335-2405-1) 12 tablet2024-06-11NoNoCurrent
71335-2405-27133524050242 TABLET in 1 BOTTLE (71335-2405-2) 42 tablet2024-06-11NoNoCurrent
71335-2405-37133524050330 TABLET in 1 BOTTLE (71335-2405-3) 30 tablet2024-06-11NoNoCurrent
71335-2405-47133524050421 TABLET in 1 BOTTLE (71335-2405-4) 21 tablet2024-06-11NoNoCurrent
71335-2405-57133524050520 TABLET in 1 BOTTLE (71335-2405-5) 20 tablet2024-06-11NoNoCurrent
71335-2405-67133524050690 TABLET in 1 BOTTLE (71335-2405-6) 90 tablet2024-06-11NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dexamethasone Tablets, USP Rx onlyBryant Ranch Prepack2024-06-11HUMAN PRESCRIPTION DRUG LABEL1