Fludrocortisone Acetate

Product NDC
70954-252
11-digit product format
709540252
Labeler code
70954
Product ID
70954-252_96dbbf53-962b-49a4-a60d-91ae0b9fb9ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludrocortisone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA215279
Marketing category
ANDA
Marketing start
2022-06-02
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
70954-252-10Fludrocortisone Acetate30 in 1 BOTTLETABLET301
70954-252-20Fludrocortisone Acetate100 in 1 BOTTLETABLET1001
70954-252-30Fludrocortisone Acetate500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-252-20EA - Each70954-2525f396e07-2b52-4e0b-8049-24cb3481e66e12022-07-06
70954-252-30EA - Each70954-25204c37ffb-aee7-430e-9986-74b10d5cefe212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-252FLUDROCORTISONE ACETATE TABLET [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 3 package rows20220604_96dbbf53-962b-49a4-a60d-91ae0b9fb9ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313979fludrocortisone acetate 0.1 MG Oral TabletPSN3d6f1a89-ea11-474d-aaca-64fea02a3beb100
313979fludrocortisone acetate 0.1 MG Oral TabletSCD3d6f1a89-ea11-474d-aaca-64fea02a3beb100
313979fludrocortisone acetate 0.1 MG Oral TabletPSN933e28ef-05e8-419e-a786-21eab67f33a22
313979fludrocortisone acetate 0.1 MG Oral TabletSCD933e28ef-05e8-419e-a786-21eab67f33a22
313979fludrocortisone acetate 0.1 MG Oral TabletPSN96dbbf53-962b-49a4-a60d-91ae0b9fb9ff1
313979fludrocortisone acetate 0.1 MG Oral TabletSCD96dbbf53-962b-49a4-a60d-91ae0b9fb9ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-252-107095402521030 TABLET in 1 BOTTLE (70954-252-10) 30 tablet2022-06-020000-00-00NoNoCurrent
70954-252-2070954025220100 TABLET in 1 BOTTLE (70954-252-20) 100 tablet2022-06-020000-00-00NoNoCurrent
70954-252-3070954025230500 TABLET in 1 BOTTLE (70954-252-30) 500 tablet2022-06-020000-00-00NoNoCurrent