Ibuprofen

Product NDC
63629-1468
11-digit product format
636291468
Labeler code
63629
Product ID
63629-1468_ffbc9f9d-60df-4552-80fa-e29c831ecc41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075682
Marketing category
ANDA
Marketing start
2008-11-20
Substance
IBUPROFEN
Active strength
400 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
63629-1468-12020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-22020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-32020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-42020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-52020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-62020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-72020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-82020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-92020-06-20C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-12020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-22020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-32020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-42020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-52020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-62020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-72020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-82020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets
63629-1468-92020-01-31C16284748780-19d75b9d0-c124-f424-e053-dadaa90a57ceIBU ™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1468-1Ibuprofen20 in 1 BOTTLETABLET2018
63629-1468-2Ibuprofen30 in 1 BOTTLETABLET3018
63629-1468-3Ibuprofen40 in 1 BOTTLETABLET4018
63629-1468-4Ibuprofen60 in 1 BOTTLETABLET6018
63629-1468-5Ibuprofen90 in 1 BOTTLETABLET9018
63629-1468-6Ibuprofen120 in 1 BOTTLETABLET12018
63629-1468-7Ibuprofen100 in 1 BOTTLETABLET10018
63629-1468-8Ibuprofen21 in 1 BOTTLETABLET2118
63629-1468-9Ibuprofen15 in 1 BOTTLETABLET1518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1468-1EA - Each63629-14686830dd64-219b-43d6-ad6c-4a4534b8dfd312012-07-24
63629-1468-2EA - Each63629-1468720646b2-f777-4d41-b599-8a25d30d6dd612012-07-24
63629-1468-3EA - Each63629-1468050142c3-283b-4767-8b4f-e578d8c424ba12012-07-24
63629-1468-4EA - Each63629-14680853df21-a11e-4430-9971-4c487cff6bc312012-07-24
63629-1468-5EA - Each63629-14683de75720-16e5-4418-a749-94e945affbaa12015-02-02
63629-1468-6EA - Each63629-146816e28516-28e0-4bc2-8cdd-60b4ed499a5b12015-02-02
63629-1468-7EA - Each63629-14685c618d30-8170-4255-b1e9-acf420eba75c12015-02-02
63629-1468-8EA - Each63629-146824fdded6-c0e2-4bae-ab52-a7cb0d472c6512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBU (IBUPROFEN) TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1468IBUPROFEN TABLET [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 9 package rows20241108_7650f84b-92f2-4065-8ef2-f5de5bd7002b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN7650f84b-92f2-4065-8ef2-f5de5bd7002b18
197805ibuprofen 400 MG Oral TabletSCD7650f84b-92f2-4065-8ef2-f5de5bd7002b18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1468-16362914680120 TABLET in 1 BOTTLE (63629-1468-1) 20 tablet2011-10-270000-00-00NoNoCurrent
63629-1468-26362914680230 TABLET in 1 BOTTLE (63629-1468-2) 30 tablet2024-10-290000-00-00NoNoCurrent
63629-1468-36362914680340 TABLET in 1 BOTTLE (63629-1468-3) 40 tablet2024-10-290000-00-00NoNoCurrent
63629-1468-46362914680460 TABLET in 1 BOTTLE (63629-1468-4) 60 tablet2024-10-290000-00-00NoNoCurrent
63629-1468-56362914680590 TABLET in 1 BOTTLE (63629-1468-5) 90 tablet2011-04-290000-00-00NoNoCurrent
63629-1468-663629146806120 TABLET in 1 BOTTLE (63629-1468-6) 120 tablet2012-09-260000-00-00NoNoCurrent
63629-1468-763629146807100 TABLET in 1 BOTTLE (63629-1468-7) 100 tablet2011-01-210000-00-00NoNoCurrent
63629-1468-86362914680821 TABLET in 1 BOTTLE (63629-1468-8) 21 tablet2012-01-100000-00-00NoNoCurrent
63629-1468-96362914680915 TABLET in 1 BOTTLE (63629-1468-9) 15 tablet2013-12-040000-00-00NoNoCurrent