FDA.reportPublic FDA data

Ibuprofen

Product NDC
70010-066
11-digit product format
700100066
Labeler code
70010
Product ID
70010-066_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
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
70010-066-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1003
70010-066-03Ibuprofen30 in 1 BOTTLETABLET, FILM COATED303
70010-066-05Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5003
70010-066-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10003
70010-066-50Ibuprofen50 in 1 BOTTLETABLET, FILM COATED503
70010-066-80Ibuprofen10 in 1 BLISTER PACKTABLET, FILM COATED103
70010-066-80Ibuprofen7 in 1 CARTONTABLET, FILM COATED73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-066-01EA - Each70010-0669bee0639-6781-449b-bc81-57ddb859067112026-03-17
70010-066-03EA - Each70010-066a7dae984-fdd2-44f9-98fd-211c40221c8a12026-03-17
70010-066-05EA - Each70010-066db3c58cb-77fb-42fe-8547-044ad4f0f4fd12026-03-17
70010-066-10EA - Each70010-0664f53f84b-a35e-4488-b4d4-a2d00096a60d12026-03-17
70010-066-50EA - Each70010-066e17639f5-7a96-4074-9a84-0df9577cba7e12026-03-17

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
70010-066-0170010006601100 TABLET, FILM COATED in 1 BOTTLE (70010-066-01) 2026-02-18NoNoCurrent
70010-066-037001000660330 TABLET, FILM COATED in 1 BOTTLE (70010-066-03) 2026-02-18NoNoCurrent
70010-066-0570010006605500 TABLET, FILM COATED in 1 BOTTLE (70010-066-05) 2026-02-18NoNoCurrent
70010-066-10700100066101000 TABLET, FILM COATED in 1 BOTTLE (70010-066-10) 2026-02-18NoNoCurrent
70010-066-507001000665050 TABLET, FILM COATED in 1 BOTTLE (70010-066-50) 2026-02-18NoNoCurrent
70010-066-80700100066807 BLISTER PACK in 1 CARTON (70010-066-80) / 10 TABLET, FILM COATED in 1 BLISTER PACK7 blister pack2026-02-18NoNoCurrent
70010-066-877001000668721000 TABLET, FILM COATED in 1 POUCH (70010-066-87)18-FEB-26Current