FDA.reportPublic FDA data

IBUPROFEN

Product NDC
61919-621
11-digit product format
619190621
Labeler code
61919
Product ID
61919-621_d61cc7c2-88c6-400d-e053-2a95a90ad7e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075682
Marketing category
ANDA
Marketing start
2019-08-20
Marketing end
0000-00-00
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
2023-12-31
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
61919-621-712020-01-31C16284748780-19d75b9d0-cf94-f424-e053-dadaa90a57ceIBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-621-90IBU90 in 1 BOTTLETABLET902
61919-621-15IBU15 in 1 BOTTLETABLET151
61919-621-21IBU21 in 1 BOTTLETABLET211
61919-621-30IBU30 in 1 BOTTLETABLET301
61919-621-40IBU40 in 1 BOTTLETABLET401
61919-621-60IBU60 in 1 BOTTLETABLET601
61919-621-71IBU100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-621-15EA - Each61919-621d037e89f-55e4-4136-a9bd-2e5dac0a2c4c12019-09-05
61919-621-21EA - Each61919-621e18facbc-5254-40d2-9ff1-4186c2198adb12019-09-05
61919-621-30EA - Each61919-62190ecf97d-ff8a-49a1-a269-5524a20161a212019-06-19
61919-621-40EA - Each61919-6218a510f61-7869-40a4-a0ea-db5a7af435e312019-07-02
61919-621-60EA - Each61919-621e8fa2138-0e55-4ccb-914c-81dc091c3e0a12019-09-05
61919-621-71EA - Each61919-621cfbbb097-8c19-4fb4-99a6-abea61f681bb12019-09-05
61919-621-72EA - Each61919-6219edb9bb2-594f-4609-8197-560dd83a83b812019-09-05
61919-621-90EA - Each61919-621f85a158f-de2a-4269-a475-ff997128d8e412016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-621IBU TABLET [DIRECTRX]2Legacy NDC, 1 package rows20190627_281fdc28-fe0f-3a47-e054-00144ff88e88.zip
61919-621IBU TABLET [DIRECT _RX]1Legacy NDC, 1 package rows20190822_90906565-2a7c-7c9c-e053-2995a90ab639.zip
61919-621IBU TABLET [DIRECT RX]1Legacy NDC, 1 package rows20160831_3b3b9e31-6387-1260-e054-00144ff88e88.zip
61919-621IBU TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190821_908eb016-483c-359a-e053-2995a90ae845.zip
61919-621IBU TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190821_908ea6e0-5a30-4bd9-e053-2a95a90a6a20.zip
61919-621IBU TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190626_8c398737-101b-3b56-e053-2a95a90a8dc7.zip
61919-621IBU TABLET [DIRECTRX]1Legacy NDC, 1 package rows20190522_87c2db5d-84e6-1f1e-e053-2a95a90aba62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN281fdc28-fe0f-3a47-e054-00144ff88e882
197807ibuprofen 800 MG Oral TabletSCD281fdc28-fe0f-3a47-e054-00144ff88e882
197807ibuprofen 800 MG Oral TabletPSN3b3b9e31-6387-1260-e054-00144ff88e881
197807ibuprofen 800 MG Oral TabletPSN87c2db5d-84e6-1f1e-e053-2a95a90aba621
197807ibuprofen 800 MG Oral TabletPSN8c398737-101b-3b56-e053-2a95a90a8dc71
197807ibuprofen 800 MG Oral TabletPSN908ea6e0-5a30-4bd9-e053-2a95a90a6a201
197807ibuprofen 800 MG Oral TabletPSN908eb016-483c-359a-e053-2995a90ae8451
197807ibuprofen 800 MG Oral TabletPSN90906565-2a7c-7c9c-e053-2995a90ab6391
197807ibuprofen 800 MG Oral TabletSCD3b3b9e31-6387-1260-e054-00144ff88e881
197807ibuprofen 800 MG Oral TabletSCD87c2db5d-84e6-1f1e-e053-2a95a90aba621
197807ibuprofen 800 MG Oral TabletSCD8c398737-101b-3b56-e053-2a95a90a8dc71
197807ibuprofen 800 MG Oral TabletSCD908ea6e0-5a30-4bd9-e053-2a95a90a6a201
197807ibuprofen 800 MG Oral TabletSCD908eb016-483c-359a-e053-2995a90ae8451
197807ibuprofen 800 MG Oral TabletSCD90906565-2a7c-7c9c-e053-2995a90ab6391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-621-156191906211515 in 1 BOTTLEHistorical
61919-621-216191906212121 in 1 BOTTLEHistorical
61919-621-306191906213030 in 1 BOTTLEHistorical
61919-621-406191906214040 in 1 BOTTLEHistorical
61919-621-606191906216060 in 1 BOTTLEHistorical
61919-621-7161919062171100 in 1 BOTTLEHistorical
61919-621-7261919062172120 TABLET in 1 BOTTLE (61919-621-72) 120 tablet2019-08-200000-00-00NoNoCurrent
61919-621-906191906219090 in 1 BOTTLEHistorical