FDA.reportPublic FDA data

Ibuprofen

Product NDC
63629-1470
11-digit product format
636291470
Labeler code
63629
Product ID
63629-1470_fa931f19-3b64-492e-9bd6-0be85e037dc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Substance
IBUPROFEN
Active strength
800 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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
63629-1470-02020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-12020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-22020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-32020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-42020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-52020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-62020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-72020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-82020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-92020-07-07C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-02020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-12020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-22020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-32020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-42020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-52020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-62020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-72020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-82020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
63629-1470-92020-01-31C16284748780-19d75b9cf-cef9-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1470-0Ibuprofen84 in 1 BOTTLETABLET841007
63629-1470-1Ibuprofen20 in 1 BOTTLETABLET201007
63629-1470-2Ibuprofen42 in 1 BOTTLETABLET421007
63629-1470-3Ibuprofen40 in 1 BOTTLETABLET401007
63629-1470-4Ibuprofen21 in 1 BOTTLETABLET211007
63629-1470-5Ibuprofen30 in 1 BOTTLETABLET301007
63629-1470-6Ibuprofen90 in 1 BOTTLETABLET901007
63629-1470-7Ibuprofen100 in 1 BOTTLETABLET1001007
63629-1470-8Ibuprofen120 in 1 BOTTLETABLET1201007
63629-1470-9Ibuprofen60 in 1 BOTTLETABLET601007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1470-0EA - Each63629-14704ff58bef-ef76-48fb-ac3e-b3fb128be59f12013-02-13
63629-1470-1EA - Each63629-14703b822ac3-9c09-4c03-97ba-56611712fd7a12013-02-13
63629-1470-2EA - Each63629-14708cc71aa9-d5e0-48fa-a905-e2577a81dff912013-02-13
63629-1470-3EA - Each63629-1470d5cdb028-fb42-41fd-9165-6018e4423f1b12013-02-13
63629-1470-4EA - Each63629-1470520e0b7f-422a-4d67-9cc3-18d06ba12de412013-02-13
63629-1470-5EA - Each63629-1470ca5ee82c-1708-499c-8c85-edbc2ddeed0012013-02-13
63629-1470-6EA - Each63629-14707b4d2127-4085-420d-b271-16350e587c9b12013-02-13
63629-1470-7EA - Each63629-147026a69247-dd60-4b72-97d8-eb6a6b03b90612013-02-13
63629-1470-8EA - Each63629-1470703cdcd6-438d-4109-afa6-22f670c1e65a12013-02-13
63629-1470-9EA - Each63629-1470292df110-f4c9-4310-8a07-22dfd79ebe3012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [BRYANT RANCH PREPACK]1000
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1470IBUPROFEN TABLET [BRYANT RANCH PREPACK]1007Current NDC, Legacy NDC, 10 package rows20240117_e90c573d-eb0f-45a5-94d1-efdd3d2b7a11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNe90c573d-eb0f-45a5-94d1-efdd3d2b7a111007
197807ibuprofen 800 MG Oral TabletSCDe90c573d-eb0f-45a5-94d1-efdd3d2b7a111007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1470-06362914700084 TABLET in 1 BOTTLE (63629-1470-0) 84 tablet2010-03-020000-00-00NoNoCurrent
63629-1470-16362914700120 TABLET in 1 BOTTLE (63629-1470-1) 20 tablet2021-12-210000-00-00NoNoCurrent
63629-1470-26362914700242 TABLET in 1 BOTTLE (63629-1470-2) 42 tablet2018-05-080000-00-00NoNoCurrent
63629-1470-36362914700340 TABLET in 1 BOTTLE (63629-1470-3) 40 tablet2021-12-210000-00-00NoNoCurrent
63629-1470-46362914700421 TABLET in 1 BOTTLE (63629-1470-4) 21 tablet2021-12-210000-00-00NoNoCurrent
63629-1470-56362914700530 TABLET in 1 BOTTLE (63629-1470-5) 30 tablet2021-12-210000-00-00NoNoCurrent
63629-1470-66362914700690 TABLET in 1 BOTTLE (63629-1470-6) 90 tablet2021-12-210000-00-00NoNoCurrent
63629-1470-763629147007100 TABLET in 1 BOTTLE (63629-1470-7) 100 tablet2021-12-210000-00-00NoNoCurrent
63629-1470-863629147008120 TABLET in 1 BOTTLE (63629-1470-8) 120 tablet2021-12-210000-00-00NoNoCurrent
63629-1470-96362914700960 TABLET in 1 BOTTLE (63629-1470-9) 60 tablet2021-12-210000-00-00NoNoCurrent