Otezla

Product NDC
70518-3155
11-digit product format
705183155
Labeler code
70518
Product ID
70518-3155_c7407311-2c06-903d-e053-2995a90af881
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apremilast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA205437
Marketing category
NDA
Marketing start
2021-07-14
Marketing end
0000-00-00
Substance
APREMILAST
Active strength
30 mg/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [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
70518-3155-02023-03-17C16284748780-1f386c64a-3059-0266-e053-dadaa90a7c1aa3fd0397-680e-46de-832a-5ff9e64a05b5
70518-3155-02023-01-30C16284748780-1f386c64a-3059-0266-e053-dadaa90a7c1aa3fd0397-680e-46de-832a-5ff9e64a05b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3155-07051831550030 POUCH in 1 BOX (70518-3155-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3155-1) 30 pouch2021-07-140000-00-00NoNoCurrent