CounterAct

Product NDC
54473-308
11-digit product format
544730308
Labeler code
54473
Product ID
54473-308_f2057d6a-e22d-4d60-e053-2a95a90a3c42
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Melaleuca, Inc
Application
ANDA091239
Marketing category
ANDA
Marketing start
2019-08-15
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
2024-12-31
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
54473-308-502025-01-30C16284748780-12cef2736-8c26-d83d-e063-dadaa90ab31fCounterAct IB Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-308-50CounterActIB1 in 1 BOXTABLET, COATED12
54473-308-50CounterActIB50 in 1 BOTTLETABLET, COATED502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-308COUNTERACT IB (IBUPROFEN) TABLET, COATED [MELALEUCA, INC]2Legacy NDC, 2 package rows20230112_90305282-f301-42c4-e053-2a95a90a6336.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101919Counteract IB 200 MG Oral TabletPSN90305282-f301-42c4-e053-2a95a90a63362
310965ibuprofen 200 MG Oral TabletPSN90305282-f301-42c4-e053-2a95a90a63362
1101919ibuprofen 200 MG Oral Tablet [Counteract IB]SBD90305282-f301-42c4-e053-2a95a90a63362
310965ibuprofen 200 MG Oral TabletSCD90305282-f301-42c4-e053-2a95a90a63362
1101919Counteract IB 200 MG Oral TabletSY90305282-f301-42c4-e053-2a95a90a63362
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY90305282-f301-42c4-e053-2a95a90a63362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-308-50544730308501 BOTTLE in 1 BOX (54473-308-50) > 50 TABLET, COATED in 1 BOTTLE1 bottle2019-08-150000-00-00NoNoCurrent