FDA.reportPublic FDA data

Ibuprofen

Product NDC
63629-1467
11-digit product format
636291467
Labeler code
63629
Product ID
63629-1467_8445f638-124d-40e8-82ea-39dfa70f8a6b
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075010
Marketing category
ANDA
Marketing start
2004-01-01
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
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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
63629-1467-02021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-12021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-22021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-32021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-42021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-52021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-62021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-72021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-82021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-92021-09-10C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-02019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-12019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-22019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-32019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-42019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-52019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-62019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-72019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-82019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941
63629-1467-92019-11-27C16284748780-19855e2a2-4971-60a7-e053-dbdaa90a05bdGC 941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1467-0Ibuprofen90 in 1 BOTTLETABLET, FILM COATED901011
63629-1467-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED201011
63629-1467-2Ibuprofen15 in 1 BOTTLETABLET, FILM COATED151011
63629-1467-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED301011
63629-1467-4Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001011
63629-1467-5Ibuprofen60 in 1 BOTTLETABLET, FILM COATED601011
63629-1467-6Ibuprofen50 in 1 BOTTLETABLET, FILM COATED501011
63629-1467-7Ibuprofen40 in 1 BOTTLETABLET, FILM COATED401011
63629-1467-8Ibuprofen10 in 1 BOTTLETABLET, FILM COATED101011
63629-1467-9Ibuprofen56 in 1 BOTTLETABLET, FILM COATED561011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1467-0EA - Each63629-146753fe949d-6cd5-4bb4-ae29-de7974238bc612023-09-05
63629-1467-1EA - Each63629-1467c7728c0c-b3a6-4999-852c-687334c1480512014-08-01
63629-1467-2EA - Each63629-1467f356b635-2fac-4455-b326-74418c1ff98912014-08-01
63629-1467-3EA - Each63629-1467383a7fad-fdb7-47cf-8ed0-4d8be5fe4b5e12014-08-01
63629-1467-4EA - Each63629-1467b5044165-5590-44d9-8fa2-c64997ada3ef12014-08-01
63629-1467-5EA - Each63629-14675cc0ae98-6534-465f-8c8d-f0c6fc73af0012014-08-01
63629-1467-6EA - Each63629-14674bcf0cfd-689c-4a4e-9823-db9e6373805212014-08-01
63629-1467-7EA - Each63629-14678cd72676-03ac-4d76-b39f-2bf6aa93a44912014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1467IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 10 package rows20231116_8fafa916-733a-4c7d-99da-6ca2ed54e1e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8fafa916-733a-4c7d-99da-6ca2ed54e1e41011
310965ibuprofen 200 MG Oral TabletSCD8fafa916-733a-4c7d-99da-6ca2ed54e1e41011
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8fafa916-733a-4c7d-99da-6ca2ed54e1e41011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1467-06362914670090 TABLET, FILM COATED in 1 BOTTLE (63629-1467-0) 2013-11-200000-00-00NoNoCurrent
63629-1467-16362914670120 TABLET, FILM COATED in 1 BOTTLE (63629-1467-1) 2005-07-150000-00-00NoNoCurrent
63629-1467-26362914670215 TABLET, FILM COATED in 1 BOTTLE (63629-1467-2) 2017-06-190000-00-00NoNoCurrent
63629-1467-36362914670330 TABLET, FILM COATED in 1 BOTTLE (63629-1467-3) 2005-01-170000-00-00NoNoCurrent
63629-1467-463629146704100 TABLET, FILM COATED in 1 BOTTLE (63629-1467-4) 2006-02-210000-00-00NoNoCurrent
63629-1467-56362914670560 TABLET, FILM COATED in 1 BOTTLE (63629-1467-5) 2006-02-100000-00-00NoNoCurrent
63629-1467-66362914670650 TABLET, FILM COATED in 1 BOTTLE (63629-1467-6) 2009-01-150000-00-00NoNoCurrent
63629-1467-76362914670740 TABLET, FILM COATED in 1 BOTTLE (63629-1467-7) 2008-06-060000-00-00NoNoCurrent
63629-1467-86362914670810 TABLET, FILM COATED in 1 BOTTLE (63629-1467-8) 2010-06-140000-00-00NoNoCurrent
63629-1467-96362914670956 TABLET, FILM COATED in 1 BOTTLE (63629-1467-9) 2010-10-290000-00-00NoNoCurrent