FDA.reportPublic FDA data

Ibuprofen

Product NDC
67877-319
11-digit product format
678770319
Labeler code
67877
Product ID
67877-319_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
400 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
IBUPROFEN400 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
67877-319-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1009
67877-319-05Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5009
67877-319-29Ibuprofen21000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKTABLET, FILM COATED210009
67877-319-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED309
67877-319-50Ibuprofen50 in 1 BOTTLETABLET, FILM COATED509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-319-01EA - Each67877-319f2d9de23-23b4-4378-b0a1-add61398de4612016-06-14
67877-319-05EA - Each67877-319dcf6f682-8d98-4c65-ad1d-74a373fd854312016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-319IBUPROFEN 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
197805ibuprofen 400 MG Oral TabletPSN20078671-536f-4b0b-a079-f90ac186a67018
197805ibuprofen 400 MG Oral TabletSCD20078671-536f-4b0b-a079-f90ac186a67018
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 TabletPSN60f1c099-5fb5-47e8-b228-11de1ef40f4b10
197805ibuprofen 400 MG Oral TabletSCD60f1c099-5fb5-47e8-b228-11de1ef40f4b10
197805ibuprofen 400 MG Oral TabletPSN9ce036ef-a22d-4fca-9a62-1b10978f7b269
197806ibuprofen 600 MG Oral TabletPSN9ce036ef-a22d-4fca-9a62-1b10978f7b269
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
197807ibuprofen 800 MG Oral TabletSCD9ce036ef-a22d-4fca-9a62-1b10978f7b269
197805ibuprofen 400 MG Oral TabletPSN908e725f-bd99-6d0b-e053-2995a90aefb28
197806ibuprofen 600 MG Oral TabletPSN908e725f-bd99-6d0b-e053-2995a90aefb28
197805ibuprofen 400 MG Oral TabletSCD908e725f-bd99-6d0b-e053-2995a90aefb28
197806ibuprofen 600 MG Oral TabletSCD908e725f-bd99-6d0b-e053-2995a90aefb28
197805ibuprofen 400 MG Oral TabletPSN444b2ea0-ec42-4bcf-b8d2-38b4b297ada06
197805ibuprofen 400 MG Oral TabletPSN6a1178c8-58df-f959-e053-2a91aa0ab6f86
197805ibuprofen 400 MG Oral TabletSCD444b2ea0-ec42-4bcf-b8d2-38b4b297ada06
197805ibuprofen 400 MG Oral TabletSCD6a1178c8-58df-f959-e053-2a91aa0ab6f86
197805ibuprofen 400 MG Oral TabletPSNab074ae8-5696-5327-e053-2a95a90a7ce35
197805ibuprofen 400 MG Oral TabletPSNf1c88d74-09b0-4b14-baea-106fbbbc54bf5
197805ibuprofen 400 MG Oral TabletSCDab074ae8-5696-5327-e053-2a95a90a7ce35
197805ibuprofen 400 MG Oral TabletSCDf1c88d74-09b0-4b14-baea-106fbbbc54bf5
197805ibuprofen 400 MG Oral TabletPSN70c0156e-3f80-ae2b-e053-2a91aa0a92cd4
197805ibuprofen 400 MG Oral TabletSCD70c0156e-3f80-ae2b-e053-2a91aa0a92cd4
197805ibuprofen 400 MG Oral TabletPSNbb6d0547-c113-42f9-8bf2-c227a55ab7582
197805ibuprofen 400 MG Oral TabletSCDbb6d0547-c113-42f9-8bf2-c227a55ab7582
197805ibuprofen 400 MG Oral TabletPSN7d7818f7-0ec5-6606-e053-2a91aa0a9ffd1
197805ibuprofen 400 MG Oral TabletSCD7d7818f7-0ec5-6606-e053-2a91aa0a9ffd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-319-0167877031901100 TABLET, FILM COATED in 1 BOTTLE (67877-319-01) 2015-12-210000-00-00NoNoCurrent
67877-319-0567877031905500 TABLET, FILM COATED in 1 BOTTLE (67877-319-05) 2015-12-210000-00-00NoNoCurrent
67877-319-296787703192921000 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-319-29) 2017-04-14NoNoHistorical
67877-319-306787703193030 TABLET, FILM COATED in 1 BOTTLE (67877-319-30) 2015-12-210000-00-00NoNoCurrent
67877-319-506787703195050 TABLET, FILM COATED in 1 BOTTLE (67877-319-50) 2015-12-210000-00-00NoNoCurrent