CORTEF

Product NDC
70518-3275
11-digit product format
705183275
Labeler code
70518
Product ID
70518-3275_d1f0a8b1-9137-7a78-e053-2a95a90a32e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA008697
Marketing category
NDA
Marketing start
2021-11-28
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3275-02023-03-23C16284748780-1f386c64a-3675-0266-e053-dadaa90a7c1a4f0d7d84-7a6c-435e-8211-7b60842dadb4
70518-3275-02023-01-30C16284748780-1f386c64a-3675-0266-e053-dadaa90a7c1a4f0d7d84-7a6c-435e-8211-7b60842dadb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3275-070518327500100 POUCH in 1 BOX (70518-3275-0) > 1 TABLET in 1 POUCH (70518-3275-1) 100 pouch2021-11-280000-00-00NoNoCurrent