FDA.reportPublic FDA data

IBUPROFEN

Product NDC
12634-191
11-digit product format
126340191
Labeler code
12634
Product ID
12634-191_36fc14a6-4944-4e90-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA075682
Marketing category
ANDA
Marketing start
2008-11-20
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 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
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-191-002020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-012020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-092020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-402020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-422020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-502020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-522020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-542020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-572020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-592020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-602020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-612020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-632020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-662020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-672020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-692020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-712020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-742020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-782020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-792020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-802020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets
12634-191-812020-01-31C16284748780-19d75b9d0-f0f4-f424-e053-dadaa90a57ceIbuprofen Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-191-00IBUPROFEN10 in 1 BOTTLETABLET107
12634-191-01IBUPROFEN100 in 1 BOTTLETABLET1007
12634-191-09IBUPROFEN35 in 1 BOTTLETABLET357
12634-191-40IBUPROFEN40 in 1 BOTTLETABLET407
12634-191-42IBUPROFEN42 in 1 BOTTLETABLET427
12634-191-50IBUPROFEN50 in 1 BOTTLETABLET507
12634-191-52IBUPROFEN12 in 1 BLISTER PACKTABLET127
12634-191-54IBUPROFEN14 in 1 BLISTER PACKTABLET147
12634-191-57IBUPROFEN20 in 1 BLISTER PACKTABLET207
12634-191-59IBUPROFEN30 in 1 BLISTER PACKTABLET307
12634-191-60IBUPROFEN60 in 1 BOTTLETABLET607
12634-191-61IBUPROFEN10 in 1 BLISTER PACKTABLET107
12634-191-63IBUPROFEN3 in 1 BLISTER PACKTABLET37
12634-191-66IBUPROFEN6 in 1 BLISTER PACKTABLET67
12634-191-67IBUPROFEN7 in 1 BLISTER PACKTABLET77
12634-191-69IBUPROFEN9 in 1 BLISTER PACKTABLET97
12634-191-71IBUPROFEN30 in 1 BOTTLETABLET307
12634-191-74IBUPROFEN24 in 1 BOTTLETABLET247
12634-191-78IBUPROFEN28 in 1 BOTTLETABLET287
12634-191-79IBUPROFEN25 in 1 BOTTLETABLET257
12634-191-80IBUPROFEN20 in 1 BOTTLETABLET207
12634-191-81IBUPROFEN21 in 1 BOTTLETABLET217
12634-191-82IBUPROFEN12 in 1 BOTTLETABLET127
12634-191-85IBUPROFEN15 in 1 BOTTLETABLET157
12634-191-91IBUPROFEN1 in 1 BLISTER PACKTABLET17
12634-191-94IBUPROFEN4 in 1 BOTTLETABLET47
12634-191-95IBUPROFEN5 in 1 BOTTLETABLET57
12634-191-96IBUPROFEN6 in 1 BOTTLETABLET67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-191-81EA - Each12634-191958ec266-e9da-4187-8996-f7c155b6cf8a12016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [APOTHECA, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [APOTHECA, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [APOTHECA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [APOTHECA, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [APOTHECA, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [APOTHECA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [APOTHECA, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET [APOTHECA, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [APOTHECA, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [APOTHECA, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [APOTHECA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-191IBUPROFEN TABLET [APOTHECA INC.]7Legacy NDC, 28 package rows20160706_0396bfec-afe1-460c-8141-e8ad877b4bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN0396bfec-afe1-460c-8141-e8ad877b4bc07
197806ibuprofen 600 MG Oral TabletPSN0396bfec-afe1-460c-8141-e8ad877b4bc07
197807ibuprofen 800 MG Oral TabletPSN0396bfec-afe1-460c-8141-e8ad877b4bc07
197805ibuprofen 400 MG Oral TabletSCD0396bfec-afe1-460c-8141-e8ad877b4bc07
197806ibuprofen 600 MG Oral TabletSCD0396bfec-afe1-460c-8141-e8ad877b4bc07
197807ibuprofen 800 MG Oral TabletSCD0396bfec-afe1-460c-8141-e8ad877b4bc07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-191-001263401910010 in 1 BOTTLEHistorical
12634-191-0112634019101100 in 1 BOTTLEHistorical
12634-191-091263401910935 in 1 BOTTLEHistorical
12634-191-401263401914040 in 1 BOTTLEHistorical
12634-191-421263401914242 in 1 BOTTLEHistorical
12634-191-501263401915050 in 1 BOTTLEHistorical
12634-191-521263401915212 in 1 BLISTER PACKHistorical
12634-191-541263401915414 in 1 BLISTER PACKHistorical
12634-191-571263401915720 in 1 BLISTER PACKHistorical
12634-191-591263401915930 in 1 BLISTER PACKHistorical
12634-191-601263401916060 in 1 BOTTLEHistorical
12634-191-611263401916110 in 1 BLISTER PACKHistorical
12634-191-63126340191633 in 1 BLISTER PACKHistorical
12634-191-66126340191666 in 1 BLISTER PACKHistorical
12634-191-67126340191677 in 1 BLISTER PACKHistorical
12634-191-69126340191699 in 1 BLISTER PACKHistorical
12634-191-711263401917130 in 1 BOTTLEHistorical
12634-191-741263401917424 in 1 BOTTLEHistorical
12634-191-781263401917828 in 1 BOTTLEHistorical
12634-191-791263401917925 in 1 BOTTLEHistorical
12634-191-801263401918020 in 1 BOTTLEHistorical
12634-191-811263401918121 in 1 BOTTLEHistorical
12634-191-821263401918212 in 1 BOTTLEHistorical
12634-191-851263401918515 in 1 BOTTLEHistorical
12634-191-91126340191911 in 1 BLISTER PACKHistorical
12634-191-94126340191944 in 1 BOTTLEHistorical
12634-191-95126340191955 in 1 BOTTLEHistorical
12634-191-96126340191966 in 1 BOTTLEHistorical