FDA.reportPublic FDA data

Ibuprofen

Product NDC
67877-320
11-digit product format
678770320
Labeler code
67877
Product ID
67877-320_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
600 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
IBUPROFEN600 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
67877-320-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1009
67877-320-05Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5009
67877-320-28Ibuprofen15000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKTABLET, FILM COATED150009
67877-320-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED309
67877-320-50Ibuprofen50 in 1 BOTTLETABLET, FILM COATED509
67877-320-01IBUPAK100 in 1 BOTTLETABLET, FILM COATED100600 mg3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-320-01EA - Each67877-320d0450000-6453-49e1-9bb0-b7e21c1e645612016-06-14
67877-320-05EA - Each67877-320a6f4da57-bf2c-4289-b473-83af4516b78e12016-06-14
67877-320-30EA - Each67877-3205d742859-7002-41b8-b4e9-b44564b90dee12017-06-15
67877-320-50EA - Each67877-32016bb54b0-01b8-4141-bc7b-9db4f03fc92e12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-320IBUPROFEN TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 5 package rows20210323_9ce036ef-a22d-4fca-9a62-1b10978f7b26.zip
67877-320IBUPAK (IBUPROFEN) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC20230112_a63f3857-92d1-0adf-e053-2995a90a3afa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNffc953f7-ed92-4528-bb2f-72c634c119fa103
197806ibuprofen 600 MG Oral TabletSCDffc953f7-ed92-4528-bb2f-72c634c119fa103
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
197806ibuprofen 600 MG Oral TabletPSNb40f39e4-a37c-4039-ae37-210c1c3c623530
197806ibuprofen 600 MG Oral TabletSCDb40f39e4-a37c-4039-ae37-210c1c3c623530
197806ibuprofen 600 MG Oral TabletPSN1e6f3ce7-e8a3-40e8-8437-523ef5277b2e23
197806ibuprofen 600 MG Oral TabletSCD1e6f3ce7-e8a3-40e8-8437-523ef5277b2e23
197806ibuprofen 600 MG Oral TabletPSNb6a6c940-daf6-4e0e-aefb-35cce87a9a5522
197806ibuprofen 600 MG Oral TabletSCDb6a6c940-daf6-4e0e-aefb-35cce87a9a5522
197806ibuprofen 600 MG Oral TabletPSNd3a7ebef-f7ab-4b34-b62e-278a8deabf7818
197806ibuprofen 600 MG Oral TabletSCDd3a7ebef-f7ab-4b34-b62e-278a8deabf7818
197806ibuprofen 600 MG Oral TabletPSN25a94943-9acc-49c8-a4da-7e07bb2c35eb14
197806ibuprofen 600 MG Oral TabletSCD25a94943-9acc-49c8-a4da-7e07bb2c35eb14
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
197805ibuprofen 400 MG Oral TabletPSN9ce036ef-a22d-4fca-9a62-1b10978f7b269
197806ibuprofen 600 MG Oral TabletPSNc859cc7a-e13a-7df4-e053-2a95a90a47d69
197806ibuprofen 600 MG Oral TabletPSNd2c7f045-e70c-4e2b-b2e0-d81a271d0a049
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 TabletSCD9ce036ef-a22d-4fca-9a62-1b10978f7b269
197806ibuprofen 600 MG Oral TabletSCD5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a9
197806ibuprofen 600 MG Oral TabletSCDc859cc7a-e13a-7df4-e053-2a95a90a47d69
197806ibuprofen 600 MG Oral TabletSCDd2c7f045-e70c-4e2b-b2e0-d81a271d0a049
197807ibuprofen 800 MG Oral TabletSCD5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a9
197807ibuprofen 800 MG Oral TabletSCD9ce036ef-a22d-4fca-9a62-1b10978f7b269
197806ibuprofen 600 MG Oral TabletPSNfd8b82a7-96fe-8bf5-e053-6394a90a39356
197806ibuprofen 600 MG Oral TabletSCDfd8b82a7-96fe-8bf5-e053-6394a90a39356
197806ibuprofen 600 MG Oral TabletPSN908e2b06-f642-db7c-e053-2995a90a51a44
197806ibuprofen 600 MG Oral TabletPSN691e0cc3-5441-7dfd-e053-2991aa0a0db04
197806ibuprofen 600 MG Oral TabletSCD691e0cc3-5441-7dfd-e053-2991aa0a0db04
197806ibuprofen 600 MG Oral TabletSCD908e2b06-f642-db7c-e053-2995a90a51a44
197806ibuprofen 600 MG Oral TabletPSNf2a08223-a73a-5461-e053-2995a90a3bce3
197806ibuprofen 600 MG Oral TabletPSNa63f3857-92d1-0adf-e053-2995a90a3afa3
197806ibuprofen 600 MG Oral TabletPSN88771e2d-8cb5-1f44-e053-2a95a90a33ce3
197806ibuprofen 600 MG Oral TabletSCDf2a08223-a73a-5461-e053-2995a90a3bce3
197806ibuprofen 600 MG Oral TabletSCDa63f3857-92d1-0adf-e053-2995a90a3afa3
197806ibuprofen 600 MG Oral TabletSCD88771e2d-8cb5-1f44-e053-2a95a90a33ce3
197806ibuprofen 600 MG Oral TabletPSN57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197806ibuprofen 600 MG Oral TabletPSN4d95bccd-8280-4d03-a574-927669c7cda02
197806ibuprofen 600 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197806ibuprofen 600 MG Oral TabletPSN894a5d14-e405-43ac-a5a2-0b4de5b284742
197807ibuprofen 800 MG Oral TabletPSN57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197807ibuprofen 800 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197806ibuprofen 600 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22
197806ibuprofen 600 MG Oral TabletSCD57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197806ibuprofen 600 MG Oral TabletSCD4d95bccd-8280-4d03-a574-927669c7cda02
197806ibuprofen 600 MG Oral TabletSCD894a5d14-e405-43ac-a5a2-0b4de5b284742
197807ibuprofen 800 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletSCD57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197806ibuprofen 600 MG Oral TabletPSN4a86a190-da5d-4b7a-a05f-e3e7ccbfa6031
197806ibuprofen 600 MG Oral TabletPSNe0a69c81-0bc0-46aa-b946-51be5a6333bf1
197806ibuprofen 600 MG Oral TabletSCD4a86a190-da5d-4b7a-a05f-e3e7ccbfa6031
197806ibuprofen 600 MG Oral TabletSCDe0a69c81-0bc0-46aa-b946-51be5a6333bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-320-0167877032001100 TABLET, FILM COATED in 1 BOTTLE (67877-320-01) 2015-12-210000-00-00NoNoCurrent
67877-320-0567877032005500 TABLET, FILM COATED in 1 BOTTLE (67877-320-05) 2015-12-210000-00-00NoNoCurrent
67877-320-286787703202815000 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-320-28) 2017-04-14NoNoCurrent
67877-320-306787703203030 TABLET, FILM COATED in 1 BOTTLE (67877-320-30) 2015-12-210000-00-00NoNoCurrent
67877-320-506787703205050 TABLET, FILM COATED in 1 BOTTLE (67877-320-50) 2015-12-210000-00-00NoNoCurrent