FDA.reportPublic FDA data

Ibuprofen

Product NDC
67877-321
11-digit product format
678770321
Labeler code
67877
Product ID
67877-321_8050d9d9-0b0b-4136-be37-a824114f7ea0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-321-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1009
67877-321-05Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5009
67877-321-27Ibuprofen11400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKTABLET, FILM COATED114009
67877-321-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED309
67877-321-50Ibuprofen50 in 1 BOTTLETABLET, FILM COATED509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-321-01EA - Each67877-321badbd35a-56d9-4946-be55-4e29e101466812016-05-16
67877-321-05EA - Each67877-321c7bc4e4f-8b87-4054-9182-71a85d0ae80a12016-06-14
67877-321-30EA - Each67877-32190516d5e-45be-4e55-af12-be0cf06c351b12017-06-15
67877-321-50EA - Each67877-321f4a95c2f-23c7-4863-8d6c-90cce2e4164f12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-321IBUPROFEN TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 5 package rows20210323_9ce036ef-a22d-4fca-9a62-1b10978f7b26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197806ibuprofen 600 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197807ibuprofen 800 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197805ibuprofen 400 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955
197806ibuprofen 600 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955
197807ibuprofen 800 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955
197805ibuprofen 400 MG Oral TabletPSNfd691a4a-8010-45e6-b3da-b26374792f2444
197807ibuprofen 800 MG Oral TabletPSNfd691a4a-8010-45e6-b3da-b26374792f2444
197805ibuprofen 400 MG Oral TabletSCDfd691a4a-8010-45e6-b3da-b26374792f2444
197807ibuprofen 800 MG Oral TabletSCDfd691a4a-8010-45e6-b3da-b26374792f2444
197807ibuprofen 800 MG Oral TabletPSN8553e29a-7f6f-4ff8-9991-836e619c504d41
197807ibuprofen 800 MG Oral TabletSCD8553e29a-7f6f-4ff8-9991-836e619c504d41
197807ibuprofen 800 MG Oral TabletPSN0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d818
197807ibuprofen 800 MG Oral TabletPSN421156d2-85dc-4680-b2b4-d15b67539e8718
197807ibuprofen 800 MG Oral TabletSCD421156d2-85dc-4680-b2b4-d15b67539e8718
197807ibuprofen 800 MG Oral TabletSCD0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d818
197807ibuprofen 800 MG Oral TabletPSN560e4e05-21e0-4b2a-ab2f-872b5dbb390117
197807ibuprofen 800 MG Oral TabletSCD560e4e05-21e0-4b2a-ab2f-872b5dbb390117
197805ibuprofen 400 MG Oral TabletPSNa4c74188-9af6-422c-abd9-087a8ab4b43a12
197806ibuprofen 600 MG Oral TabletPSNa4c74188-9af6-422c-abd9-087a8ab4b43a12
197807ibuprofen 800 MG Oral TabletPSNa4c74188-9af6-422c-abd9-087a8ab4b43a12
197805ibuprofen 400 MG Oral TabletSCDa4c74188-9af6-422c-abd9-087a8ab4b43a12
197806ibuprofen 600 MG Oral TabletSCDa4c74188-9af6-422c-abd9-087a8ab4b43a12
197807ibuprofen 800 MG Oral TabletSCDa4c74188-9af6-422c-abd9-087a8ab4b43a12
197807ibuprofen 800 MG Oral TabletPSNb81c6495-8b30-41ef-8a0f-4cbfd87f1eb411
197807ibuprofen 800 MG Oral TabletSCDb81c6495-8b30-41ef-8a0f-4cbfd87f1eb411
197807ibuprofen 800 MG Oral TabletPSNaf9ac948-440c-5abf-e053-2995a90af2b510
197807ibuprofen 800 MG Oral TabletSCDaf9ac948-440c-5abf-e053-2995a90af2b510
197805ibuprofen 400 MG Oral TabletPSN9ce036ef-a22d-4fca-9a62-1b10978f7b269
197806ibuprofen 600 MG Oral TabletPSN5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a9
197806ibuprofen 600 MG Oral TabletPSN9ce036ef-a22d-4fca-9a62-1b10978f7b269
197807ibuprofen 800 MG Oral TabletPSN5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a9
197807ibuprofen 800 MG Oral TabletPSN9ce036ef-a22d-4fca-9a62-1b10978f7b269
197805ibuprofen 400 MG Oral TabletSCD9ce036ef-a22d-4fca-9a62-1b10978f7b269
197806ibuprofen 600 MG Oral TabletSCD5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a9
197806ibuprofen 600 MG Oral TabletSCD9ce036ef-a22d-4fca-9a62-1b10978f7b269
197807ibuprofen 800 MG Oral TabletSCD9ce036ef-a22d-4fca-9a62-1b10978f7b269
197807ibuprofen 800 MG Oral TabletSCD5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a9
197807ibuprofen 800 MG Oral TabletPSN90b8b80e-ab30-3590-e053-2a95a90a70ef7
197807ibuprofen 800 MG Oral TabletSCD90b8b80e-ab30-3590-e053-2a95a90a70ef7
197807ibuprofen 800 MG Oral TabletPSN4cfa7cec-81e6-6c0a-e054-00144ff8d46c6
197807ibuprofen 800 MG Oral TabletPSN2dc3108f-d917-40c6-865d-c900cf055d1c6
197807ibuprofen 800 MG Oral TabletPSNd0198bdc-fe2b-4b09-8f78-9e5a7f6ae7846
197807ibuprofen 800 MG Oral TabletPSNab80abe6-f7db-479b-e053-2a95a90a90e36
197807ibuprofen 800 MG Oral TabletSCD4cfa7cec-81e6-6c0a-e054-00144ff8d46c6
197807ibuprofen 800 MG Oral TabletSCD2dc3108f-d917-40c6-865d-c900cf055d1c6
197807ibuprofen 800 MG Oral TabletSCDd0198bdc-fe2b-4b09-8f78-9e5a7f6ae7846
197807ibuprofen 800 MG Oral TabletSCDab80abe6-f7db-479b-e053-2a95a90a90e36
197807ibuprofen 800 MG Oral TabletPSN888a5dbc-9464-e272-e053-2a95a90ad6874
197807ibuprofen 800 MG Oral TabletPSN2f12a20c-4293-d18a-e063-6294a90a3afc4
197807ibuprofen 800 MG Oral TabletSCD888a5dbc-9464-e272-e053-2a95a90ad6874
197807ibuprofen 800 MG Oral TabletSCD2f12a20c-4293-d18a-e063-6294a90a3afc4
197806ibuprofen 600 MG Oral TabletPSN57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197806ibuprofen 600 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletPSN34885247-d379-4c3c-b891-b02f31a203b52
197807ibuprofen 800 MG Oral TabletPSNb493bf76-1e8b-4e72-bef6-aca4efc69cbe2
197807ibuprofen 800 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletPSN57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197807ibuprofen 800 MG Oral TabletPSN6637efdc-996a-75b9-e053-2a91aa0a90462
197806ibuprofen 600 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22
197806ibuprofen 600 MG Oral TabletSCD57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197807ibuprofen 800 MG Oral TabletSCD57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197807ibuprofen 800 MG Oral TabletSCDb493bf76-1e8b-4e72-bef6-aca4efc69cbe2
197807ibuprofen 800 MG Oral TabletSCD34885247-d379-4c3c-b891-b02f31a203b52
197807ibuprofen 800 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletSCD6637efdc-996a-75b9-e053-2a91aa0a90462
197807ibuprofen 800 MG Oral TabletPSNbc06d982-d670-ef05-e053-2a95a90a973a1
197807ibuprofen 800 MG Oral TabletPSNe4644cb5-7fae-456a-98d3-62ba521cd0b21
197807ibuprofen 800 MG Oral TabletPSN7d786d5e-3864-daba-e053-2991aa0ab6291
197807ibuprofen 800 MG Oral TabletSCDbc06d982-d670-ef05-e053-2a95a90a973a1
197807ibuprofen 800 MG Oral TabletSCD7d786d5e-3864-daba-e053-2991aa0ab6291
197807ibuprofen 800 MG Oral TabletSCDe4644cb5-7fae-456a-98d3-62ba521cd0b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-321-0167877032101100 TABLET, FILM COATED in 1 BOTTLE (67877-321-01) 2015-12-210000-00-00NoNoCurrent
67877-321-0567877032105500 TABLET, FILM COATED in 1 BOTTLE (67877-321-05) 2015-12-210000-00-00NoNoCurrent
67877-321-276787703212711400 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-321-27) 2017-04-14NoNoHistorical
67877-321-306787703213030 TABLET, FILM COATED in 1 BOTTLE (67877-321-30) 2015-12-210000-00-00NoNoCurrent
67877-321-506787703215050 TABLET, FILM COATED in 1 BOTTLE (67877-321-50) 2015-12-210000-00-00NoNoCurrent