Bicalutamide

Product NDC
70518-2993
11-digit product format
705182993
Labeler code
70518
Product ID
70518-2993_ba9c81ea-576b-6d81-e053-2a95a90a5ddb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bicalutamide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078917
Marketing category
ANDA
Marketing start
2021-01-15
Marketing end
0000-00-00
Substance
BICALUTAMIDE
Active strength
50 mg/1
Pharmacologic classes
Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
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
70518-2993-02023-03-14C16284748780-1f386c64a-47f7-0266-e053-dadaa90a7c1ac6729c9c-3df6-48e1-842b-e59bc2eda60c
70518-2993-02023-01-30C16284748780-1f386c64a-47f7-0266-e053-dadaa90a7c1ac6729c9c-3df6-48e1-842b-e59bc2eda60c

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2993-07051829930030 POUCH in 1 BOX (70518-2993-0) > 1 TABLET in 1 POUCH (70518-2993-1) 30 pouch2021-01-150000-00-00NoNoCurrent