Ibuprofen

Product NDC
52605-120
11-digit product format
526050120
Labeler code
52605
Product ID
52605-120_a5e2a7fd-dc7e-4f1b-9436-41b9834caaab
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Polygen Pharmaceuticals LLC
Application
ANDA091237
Marketing category
ANDA
Marketing start
2013-07-02
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52605-120-012020-01-31C16284748780-19d75b9d0-6a12-f424-e053-dadaa90a57cea5e2a7fd-dc7e-4f1b-9436-41b9834caaab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52605-120-01Ibuprofen100 in 1 BOTTLETABLET1001
52605-120-01Ibuprofen1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52605-120IBUPROFEN TABLET [POLYGEN PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20130702_a5e2a7fd-dc7e-4f1b-9436-41b9834caaab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa5e2a7fd-dc7e-4f1b-9436-41b9834caaab1
310965ibuprofen 200 MG Oral TabletSCDa5e2a7fd-dc7e-4f1b-9436-41b9834caaab1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa5e2a7fd-dc7e-4f1b-9436-41b9834caaab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52605-120-0152605012001100 in 1 BOTTLEHistorical