Fludrocortisone acetate

Product NDC
70771-1893
11-digit product format
707711893
Labeler code
70771
Product ID
70771-1893_3d915d99-8d45-4077-990f-da0f653675a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA219251
Marketing category
ANDA
Marketing start
2024-12-02
Substance
FLUDROCORTISONE ACETATE
Active strength
.1 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDROCORTISONE ACETATE.1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV47IF0PVH4
Rxcui313979

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fff94984-a082-0061-d8a9-f1ca884c7b96Product name320250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1893-1Fludrocortisone acetate100 in 1 BOTTLETABLET1001
70771-1893-5Fludrocortisone acetate500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1893FLUDROCORTISONE ACETATE TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 2 package rows20241203_6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e1
313979fludrocortisone acetate 0.1 MG Oral TabletSCD6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1893-170771189301100 TABLET in 1 BOTTLE (70771-1893-1) 100 tablet2024-12-02NoNoHistorical
70771-1893-570771189305500 TABLET in 1 BOTTLE (70771-1893-5) 500 tablet2024-12-02NoNoHistorical