Ibuprofen

Product NDC
10544-213
11-digit product format
105440213
Labeler code
10544
Product ID
10544-213_134f38e1-34f0-040e-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078558
Marketing category
ANDA
Marketing start
2010-03-10
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-213-00Ibuprofen100 in 1 BOTTLETABLET1003
10544-213-30Ibuprofen30 in 1 BOTTLETABLET303
10544-213-40Ibuprofen40 in 1 BOTTLETABLET403
10544-213-60Ibuprofen60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-213-30EA - Each10544-21332e2d0a8-7433-4b78-b154-41657378ceeb12015-02-02
10544-213-40EA - Each10544-213b18cb764-1a97-4cda-a377-bb45147e7b2712015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-213IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]3Legacy NDC, 4 package rows20150409_ec090526-a623-4e65-8b63-916c49237275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNec090526-a623-4e65-8b63-916c492372753
197805ibuprofen 400 MG Oral TabletSCDec090526-a623-4e65-8b63-916c492372753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-213-0010544021300100 in 1 BOTTLEHistorical
10544-213-301054402133030 in 1 BOTTLEHistorical
10544-213-401054402134040 in 1 BOTTLEHistorical
10544-213-601054402136060 in 1 BOTTLEHistorical