Ibuprofen

Product NDC
36800-749
11-digit product format
368000749
Labeler code
36800
Product ID
36800-749_c1b597e6-2b92-42dd-ad3f-57ef1dee4d34
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
ANDA206568
Marketing category
ANDA
Marketing start
2018-03-31
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-749-20Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED205
36800-749-20Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
36800-749-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
36800-749-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-749IBUPROFEN CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 4 package rows20230803_627a7f4d-f4d0-4bf8-8f4f-a8def8571cc1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-749-20368000749201 BOTTLE, PLASTIC in 1 BOX (36800-749-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-03-310000-00-00NoNoCurrent
36800-749-40368000749401 BOTTLE, PLASTIC in 1 BOX (36800-749-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-03-310000-00-00NoNoCurrent