ibuprofen

Product NDC
70518-3016
11-digit product format
705183016
Labeler code
70518
Product ID
70518-3016_ba71e396-f2ab-db89-e053-2995a90a1c1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2021-02-03
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [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
70518-3016-02023-03-14C16284748780-1f386c649-f9b7-0266-e053-dadaa90a7c1a8498d5e5-746a-484d-9d5d-8dbb28e8cb95
70518-3016-02023-01-30C16284748780-1f386c649-f9b7-0266-e053-dadaa90a7c1a8498d5e5-746a-484d-9d5d-8dbb28e8cb95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3016-07051830160030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3016-0) 2021-02-030000-00-00NoNoCurrent