FDA.reportPublic FDA data

Prednisone

Product NDC
63187-807
11-digit product format
631870807
Labeler code
63187
Product ID
63187-807_69508b79-c086-493a-a46f-b9ab7c60a519
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
20 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
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615

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
63187-807-05Prednisone05 in 1 BOTTLETABLET056
63187-807-06Prednisone06 in 1 BOTTLETABLET066
63187-807-07Prednisone07 in 1 BOTTLETABLET076
63187-807-08Prednisone08 in 1 BOTTLETABLET086
63187-807-09Prednisone09 in 1 BOTTLETABLET096
63187-807-10Prednisone10 in 1 BOTTLETABLET106
63187-807-12Prednisone12 in 1 BOTTLETABLET126
63187-807-14Prednisone14 in 1 BOTTLETABLET146
63187-807-15Prednisone15 in 1 BOTTLETABLET156
63187-807-18Prednisone18 in 1 BOTTLETABLET186
63187-807-20Prednisone20 in 1 BOTTLETABLET206
63187-807-21Prednisone21 in 1 BOTTLETABLET216
63187-807-24Prednisone24 in 1 BOTTLETABLET246
63187-807-30Prednisone30 in 1 BOTTLETABLET306
63187-807-40Prednisone40 in 1 BOTTLETABLET406
63187-807-42Prednisone42 in 1 BOTTLETABLET426

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-807-05EA - Each63187-807364c4b0d-04c0-4db4-bfdc-ecde25b9aee312017-11-06
63187-807-06EA - Each63187-807691322a1-cf3f-437b-859d-c916bba76f6f12018-11-06
63187-807-07EA - Each63187-807e58bea04-bb61-4566-bc63-e305a986893512017-06-15
63187-807-10EA - Each63187-807b2532e40-4be1-40e4-96af-1fd461d0745812017-03-06
63187-807-12EA - Each63187-8077a843fca-e846-4cda-8e75-1892f5727e6412017-07-07
63187-807-15EA - Each63187-807e71e0b3c-9bf2-4749-b06a-4b034d1647cc12017-05-04
63187-807-18EA - Each63187-807c7c4246d-29e8-4b6d-b2af-dcaf2fd9d3ed12018-05-09
63187-807-20EA - Each63187-807c522ae71-19db-4cbd-b025-c149a5842bf712017-04-05
63187-807-21EA - Each63187-8074bf0d2f7-3156-44cc-85ee-22566f76e00612017-06-15
63187-807-30EA - Each63187-807d357587a-a1f2-4657-be37-6f055f29e8d912017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-807PREDNISONE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 16 package rows20191025_e4555299-af68-416f-8999-9bb703a45e77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNe4555299-af68-416f-8999-9bb703a45e776
312615prednisone 20 MG Oral TabletSCDe4555299-af68-416f-8999-9bb703a45e776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-807-05631870807055 TABLET in 1 BOTTLE (63187-807-05) 5 tablet2017-02-010000-00-00NoNoCurrent
63187-807-06631870807066 TABLET in 1 BOTTLE (63187-807-06) 6 tablet2017-02-010000-00-00NoNoCurrent
63187-807-07631870807077 TABLET in 1 BOTTLE (63187-807-07) 7 tablet2017-04-030000-00-00NoNoCurrent
63187-807-08631870807088 TABLET in 1 BOTTLE (63187-807-08) 8 tablet2017-02-010000-00-00NoNoCurrent
63187-807-09631870807099 TABLET in 1 BOTTLE (63187-807-09) 9 tablet2017-02-010000-00-00NoNoCurrent
63187-807-106318708071010 TABLET in 1 BOTTLE (63187-807-10) 10 tablet2017-02-010000-00-00NoNoCurrent
63187-807-126318708071212 TABLET in 1 BOTTLE (63187-807-12) 12 tablet2017-02-010000-00-00NoNoCurrent
63187-807-146318708071414 TABLET in 1 BOTTLE (63187-807-14) 14 tablet2018-11-010000-00-00NoNoCurrent
63187-807-156318708071515 TABLET in 1 BOTTLE (63187-807-15) 15 tablet2017-02-010000-00-00NoNoCurrent
63187-807-186318708071818 TABLET in 1 BOTTLE (63187-807-18) 18 tablet2018-03-010000-00-00NoNoCurrent
63187-807-206318708072020 TABLET in 1 BOTTLE (63187-807-20) 20 tablet2017-02-010000-00-00NoNoCurrent
63187-807-216318708072121 TABLET in 1 BOTTLE (63187-807-21) 21 tablet2017-02-010000-00-00NoNoCurrent
63187-807-246318708072424 TABLET in 1 BOTTLE (63187-807-24) 24 tablet2017-02-010000-00-00NoNoCurrent
63187-807-306318708073030 TABLET in 1 BOTTLE (63187-807-30) 30 tablet2017-02-010000-00-00NoNoCurrent
63187-807-406318708074040 TABLET in 1 BOTTLE (63187-807-40) 40 tablet2017-02-010000-00-00NoNoCurrent
63187-807-426318708074242 TABLET in 1 BOTTLE (63187-807-42) 42 tablet2017-02-010000-00-00NoNoCurrent