FDA.reportPublic FDA data

Ibuprofen

Product NDC
69842-649
11-digit product format
698420649
Labeler code
69842
Product ID
69842-649_0740ae08-441b-4dd5-bdef-d72cf3916717
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA206568
Marketing category
ANDA
Marketing start
2018-12-31
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
69842-649-802020-10-26C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts
69842-649-882020-10-26C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts
69842-649-802020-09-27C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts
69842-649-882020-09-27C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts
69842-649-802020-09-25C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts
69842-649-882020-09-25C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts
69842-649-802020-07-22C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts
69842-649-882020-07-22C16284748780-1ab0e2407-269c-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-649-80Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED805
69842-649-80Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
69842-649-88Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
69842-649-88Ibuprofen88 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED885

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-649IBUPROFEN CAPSULE, LIQUID FILLED [CVS PHARMACY]4Current NDC, Legacy NDC, 4 package rows20221123_e241ca5f-04bd-4bc9-bd0c-ca22841c4a3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNe241ca5f-04bd-4bc9-bd0c-ca22841c4a3c5
310964ibuprofen 200 MG Oral CapsuleSCDe241ca5f-04bd-4bc9-bd0c-ca22841c4a3c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-649-80698420649801 BOTTLE, PLASTIC in 1 BOX (69842-649-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-12-312027-01-31NoNoCurrent
69842-649-88698420649881 BOTTLE, PLASTIC in 1 BOX (69842-649-88) / 88 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-12-312027-01-31NoNoCurrent