Prednisone

Product NDC
67296-0140
11-digit product format
672960140
Labeler code
67296
Product ID
67296-0140_d5fbea2f-f34e-900f-e053-2995a90a3887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA085162
Marketing category
ANDA
Marketing start
1987-11-01
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0140-1Prednisone10 in 1 BOTTLETABLET105
67296-0140-2Prednisone30 in 1 BOTTLETABLET305
67296-0140-3Prednisone42 in 1 BOTTLETABLET425
67296-0140-9Prednisone9 in 1 BOTTLETABLET95

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [REDPHARM DRUG INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [REDPHARM DRUG INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [REDPHARM DRUG INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [REDPHARM DRUG INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [REDPHARM DRUG INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [REDPHARM DRUG INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0140PREDNISONE TABLET [REDPHARM DRUG INC.]5Legacy NDC, 4 package rows20240621_c8bc83d5-b9e2-4d31-a3df-8e899aac1ba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNc8bc83d5-b9e2-4d31-a3df-8e899aac1ba55
198145prednisone 10 MG Oral TabletSCDc8bc83d5-b9e2-4d31-a3df-8e899aac1ba55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0140-16729601400110 TABLET in 1 BOTTLE (67296-0140-1) 10 tablet2020-04-220000-00-00NoNoCurrent
67296-0140-26729601400230 TABLET in 1 BOTTLE (67296-0140-2) 30 tablet2011-06-240000-00-00NoNoCurrent
67296-0140-36729601400342 TABLET in 1 BOTTLE (67296-0140-3) 42 tablet2020-04-220000-00-00NoNoCurrent
67296-0140-4672960140044 TABLET in 1 BOTTLE (67296-0140-4)4 tablet1990-01-010Current
67296-0140-9672960140099 TABLET in 1 BOTTLE (67296-0140-9) 9 tablet2020-04-220000-00-00NoNoCurrent