FDA.reportPublic FDA data

PREDNISONE

Product NDC
68071-5242
11-digit product format
680715242
Labeler code
68071
Product ID
68071-5242_de3466ae-481b-8b56-e053-2a95a90aabfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210525
Marketing category
ANDA
Marketing start
2018-12-04
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5242-22022-02-07C16284748780-1d6a99b39-d758-a426-e053-dadaa90af4c2a40c8a01-3aee-8ee8-e053-2a95a90a3560
68071-5242-22022-01-28C16284748780-1d6a99b39-d758-a426-e053-dadaa90af4c2a40c8a01-3aee-8ee8-e053-2a95a90a3560

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5242-06807152420010 TABLET in 1 BOTTLE (68071-5242-0) 10 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-16807152420121 TABLET in 1 BOTTLE (68071-5242-1) 21 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-26807152420220 TABLET in 1 BOTTLE (68071-5242-2) 20 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-36807152420330 TABLET in 1 BOTTLE (68071-5242-3) 30 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-46807152420440 TABLET in 1 BOTTLE (68071-5242-4) 40 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-56807152420515 TABLET in 1 BOTTLE (68071-5242-5) 15 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-6680715242066 TABLET in 1 BOTTLE (68071-5242-6) 6 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-7680715242076 TABLET in 1 BOTTLE (68071-5242-7) 6 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-86807152420818 TABLET in 1 BOTTLE (68071-5242-8) 18 tablet2020-04-240000-00-00NoNoCurrent