FDA.reportPublic FDA data

Ibuprofen

Product NDC
70010-068
11-digit product format
700100068
Labeler code
70010
Product ID
70010-068_5125d89b-4fd5-b823-e063-6394a90a1eff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA091625
Marketing category
ANDA
Marketing start
2026-02-18
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
70010-068-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1003
70010-068-03Ibuprofen30 in 1 BOTTLETABLET, FILM COATED303
70010-068-05Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5003
70010-068-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10003
70010-068-50Ibuprofen50 in 1 BOTTLETABLET, FILM COATED503
70010-068-82Ibuprofen14 in 1 BLISTER PACKTABLET, FILM COATED143
70010-068-82Ibuprofen9 in 1 CARTONTABLET, FILM COATED93

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-068-01EA - Each70010-06858df0631-99d8-446d-9dc5-8530126f9c8b12026-03-17
70010-068-03EA - Each70010-068f9d517f6-a37c-4fae-9e92-d835aea0fd7212026-03-17
70010-068-05EA - Each70010-06874be815e-3603-4d88-80ac-36b151d4d72f12026-03-17
70010-068-10EA - Each70010-068c7dd4181-be6c-471f-8230-ea0a54721b8212026-03-17
70010-068-50EA - Each70010-0686bddc47b-6e4d-4bd3-ad5a-d93e71bc52d012026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN4aefcb3a-5dc8-b88e-e063-6294a90ac0443
197806ibuprofen 600 MG Oral TabletPSN4aefcb3a-5dc8-b88e-e063-6294a90ac0443
197807ibuprofen 800 MG Oral TabletPSN4aefcb3a-5dc8-b88e-e063-6294a90ac0443
197805ibuprofen 400 MG Oral TabletSCD4aefcb3a-5dc8-b88e-e063-6294a90ac0443
197806ibuprofen 600 MG Oral TabletSCD4aefcb3a-5dc8-b88e-e063-6294a90ac0443
197807ibuprofen 800 MG Oral TabletSCD4aefcb3a-5dc8-b88e-e063-6294a90ac0443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-068-0170010006801100 TABLET, FILM COATED in 1 BOTTLE (70010-068-01) 2026-02-18NoNoCurrent
70010-068-037001000680330 TABLET, FILM COATED in 1 BOTTLE (70010-068-03) 2026-02-18NoNoCurrent
70010-068-0570010006805500 TABLET, FILM COATED in 1 BOTTLE (70010-068-05) 2026-02-18NoNoCurrent
70010-068-10700100068101000 TABLET, FILM COATED in 1 BOTTLE (70010-068-10) 2026-02-18NoNoCurrent
70010-068-507001000685050 TABLET, FILM COATED in 1 BOTTLE (70010-068-50) 2026-02-18NoNoCurrent
70010-068-82700100068829 BLISTER PACK in 1 CARTON (70010-068-82) / 14 TABLET, FILM COATED in 1 BLISTER PACK9 blister pack2026-02-18NoNoCurrent
70010-068-897001000688911400 TABLET, FILM COATED in 1 POUCH (70010-068-89)18-FEB-26Current