FDA.reportPublic FDA data

ibuprofen

Product NDC
67877-121
11-digit product format
678770121
Labeler code
67877
Product ID
67877-121_a00b2087-03c1-4810-9543-b601b0302307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA078329
Marketing category
ANDA
Marketing start
2009-02-06
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
67877-121-052021-01-29C16284748780-1ba0f9c33-247c-a910-e053-dadaa90a0b85Ibuprofen Tablets, USP 400mg, 600mg and 800mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-121-05ibuprofen500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-121-05EA - Each67877-1211de34da5-4b35-4a36-8c31-6a239eed25ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ibuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9
ibuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [ASCEND LABORATORIES, LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-121IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]10Legacy NDC, 1 package rows20190201_07506e83-e681-4225-8c65-3e8d21d69064.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN07506e83-e681-4225-8c65-3e8d21d6906410
197806ibuprofen 600 MG Oral TabletPSN07506e83-e681-4225-8c65-3e8d21d6906410
197807ibuprofen 800 MG Oral TabletPSN07506e83-e681-4225-8c65-3e8d21d6906410
197805ibuprofen 400 MG Oral TabletSCD07506e83-e681-4225-8c65-3e8d21d6906410
197806ibuprofen 600 MG Oral TabletSCD07506e83-e681-4225-8c65-3e8d21d6906410
197807ibuprofen 800 MG Oral TabletSCD07506e83-e681-4225-8c65-3e8d21d6906410
197807ibuprofen 800 MG Oral TabletPSN6316b345-beb0-4be6-a9c6-b3881d310eff1
197807ibuprofen 800 MG Oral TabletSCD6316b345-beb0-4be6-a9c6-b3881d310eff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67877-121-0567877012105500 in 1 BOTTLEHistorical