Ibuprofen

Product NDC
58624-7010
11-digit product format
586247010
Labeler code
58624
Product ID
58624-7010_f0d5c414-1dee-411c-e053-2995a90ab83e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Shandong Xinhua Pharmaceutical Co., Ltd.
Application
ANDA207095
Marketing category
ANDA
Marketing start
2022-04-05
Marketing end
0000-00-00
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
2023-12-31
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
58624-7010-02025-01-30C16284748780-12cef2736-8e28-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58624-7010-0Ibuprofen24 in 1 BOTTLETABLET, FILM COATED242
58624-7010-0Ibuprofen1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58624-7010IBUPROFEN TABLET, FILM COATED [SHANDONG XINHUA PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20230307_f0d5cd00-e92a-9100-e053-2995a90a6dac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNf0d5cd00-e92a-9100-e053-2995a90a6dac2
310965ibuprofen 200 MG Oral TabletSCDf0d5cd00-e92a-9100-e053-2995a90a6dac2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf0d5cd00-e92a-9100-e053-2995a90a6dac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58624-7010-0586247010001 BOTTLE in 1 CARTON (58624-7010-0) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-04-050000-00-00NoNoCurrent