FDA.reportPublic FDA data

Prednisone

Product NDC
63187-300
11-digit product format
631870300
Labeler code
63187
Product ID
63187-300_7a33b3c9-ca90-4d15-aacf-5a8f91b804a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Substance
PREDNISONE
Active strength
10 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
Prednisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-300-05Prednisone5 in 1 BOTTLETABLET56
63187-300-06Prednisone6 in 1 BOTTLETABLET66
63187-300-08Prednisone8 in 1 BOTTLETABLET86
63187-300-09Prednisone9 in 1 BOTTLETABLET96
63187-300-10Prednisone10 in 1 BOTTLETABLET106
63187-300-12Prednisone12 in 1 BOTTLETABLET126
63187-300-15Prednisone15 in 1 BOTTLETABLET156
63187-300-18Prednisone18 in 1 BOTTLETABLET186
63187-300-20Prednisone20 in 1 BOTTLETABLET206
63187-300-21Prednisone21 in 1 BOTTLETABLET216
63187-300-24Prednisone24 in 1 BOTTLETABLET246
63187-300-27Prednisone27 in 1 BOTTLETABLET276
63187-300-28Prednisone28 in 1 BOTTLETABLET286
63187-300-30Prednisone30 in 1 BOTTLETABLET306
63187-300-36Prednisone36 in 1 BOTTLETABLET366
63187-300-40Prednisone40 in 1 BOTTLETABLET406
63187-300-42Prednisone42 in 1 BOTTLETABLET426

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-300-15EA - Each63187-3009b52dace-89ff-4832-aa92-bc7d81709d2c12019-06-19
63187-300-18EA - Each63187-3009f9b2b67-2348-4ce8-af66-d9db9b690c1c12019-11-12
63187-300-21EA - Each63187-30067459459-b0b0-4a84-9ec8-6fbff40fb01d12017-03-06
63187-300-24EA - Each63187-3005827e971-fe9b-46a1-9915-3780b231249a12018-01-12
63187-300-27EA - Each63187-3003c4809f0-3d63-47c1-8a95-116914ca6e3812019-11-12
63187-300-28EA - Each63187-300a6103058-1152-48a4-a85a-aa2cd9fd07df12019-11-12
63187-300-36EA - Each63187-300d9c004cb-ddc8-4eef-ad72-aba0e1d6eb8e12017-06-15
63187-300-40EA - Each63187-3005be580fe-1c28-44d4-a759-87109477688d12017-03-06
63187-300-42EA - Each63187-300e9412272-a1ee-4b6b-9712-9cac48b5a6af12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-300PREDNISONE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 17 package rows20230915_5961b1d4-6a4c-452f-b3f1-c99f3a9a6445.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN5961b1d4-6a4c-452f-b3f1-c99f3a9a64456
198145prednisone 10 MG Oral TabletSCD5961b1d4-6a4c-452f-b3f1-c99f3a9a64456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-300-05631870300055 TABLET in 1 BOTTLE (63187-300-05) 5 tablet2016-05-020000-00-00NoNoCurrent
63187-300-06631870300066 TABLET in 1 BOTTLE (63187-300-06) 6 tablet2016-05-020000-00-00NoNoCurrent
63187-300-08631870300088 TABLET in 1 BOTTLE (63187-300-08) 8 tablet2016-05-020000-00-00NoNoCurrent
63187-300-09631870300099 TABLET in 1 BOTTLE (63187-300-09) 9 tablet2016-05-020000-00-00NoNoCurrent
63187-300-106318703001010 TABLET in 1 BOTTLE (63187-300-10) 10 tablet2016-05-020000-00-00NoNoCurrent
63187-300-126318703001212 TABLET in 1 BOTTLE (63187-300-12) 12 tablet2016-05-020000-00-00NoNoCurrent
63187-300-156318703001515 TABLET in 1 BOTTLE (63187-300-15) 15 tablet2016-05-020000-00-00NoNoCurrent
63187-300-186318703001818 TABLET in 1 BOTTLE (63187-300-18) 18 tablet2017-11-010000-00-00NoNoCurrent
63187-300-206318703002020 TABLET in 1 BOTTLE (63187-300-20) 20 tablet2016-05-020000-00-00NoNoCurrent
63187-300-216318703002121 TABLET in 1 BOTTLE (63187-300-21) 21 tablet2016-05-020000-00-00NoNoCurrent
63187-300-246318703002424 TABLET in 1 BOTTLE (63187-300-24) 24 tablet2016-05-020000-00-00NoNoCurrent
63187-300-276318703002727 TABLET in 1 BOTTLE (63187-300-27) 27 tablet2017-11-010000-00-00NoNoCurrent
63187-300-286318703002828 TABLET in 1 BOTTLE (63187-300-28) 28 tablet2019-10-010000-00-00NoNoCurrent
63187-300-306318703003030 TABLET in 1 BOTTLE (63187-300-30) 30 tablet2016-05-020000-00-00NoNoCurrent
63187-300-366318703003636 TABLET in 1 BOTTLE (63187-300-36) 36 tablet2017-04-030000-00-00NoNoCurrent
63187-300-406318703004040 TABLET in 1 BOTTLE (63187-300-40) 40 tablet2016-05-020000-00-00NoNoCurrent
63187-300-426318703004242 TABLET in 1 BOTTLE (63187-300-42) 42 tablet2016-05-020000-00-00NoNoCurrent