Ibuprofen

Product NDC
68788-7268
11-digit product format
687887268
Labeler code
68788
Product ID
68788-7268_8f5f2800-6f9b-462d-9b5c-a375c85b17bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209204
Marketing category
ANDA
Marketing start
2018-09-25
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7268-12022-02-10C16284748780-1d6a99b39-40ae-a426-e053-dadaa90af4c2e3d4f976-d42f-4a9b-9a95-029fe7961e5b
68788-7268-12022-01-28C16284748780-1d6a99b39-40ae-a426-e053-dadaa90af4c2e3d4f976-d42f-4a9b-9a95-029fe7961e5b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7268-1ML - Milliliter68788-726875c7c937-4ec7-4952-90a8-a80c28d840cf12018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7268-1687887268011 BOTTLE in 1 CARTON (68788-7268-1) > 118 mL in 1 BOTTLE1 bottle2018-09-250000-00-00NoNoCurrent