FDA.reportPublic FDA data

Ibuprofen

Product NDC
70518-2902
11-digit product format
705182902
Labeler code
70518
Product ID
70518-2902_503587fe-bff9-1089-e063-6294a90af099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2020-10-06
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
Rxcui197806

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2902-02022-02-09C16284748780-1d6a99b39-61d7-a426-e053-dadaa90af4c2Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
70518-2902-02022-01-28C16284748780-1d6a99b39-61d7-a426-e053-dadaa90af4c2Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2902-0Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED305
70518-2902-1Ibuprofen50 in 1 BOXTABLET, FILM COATED505
70518-2902-2Ibuprofen1 in 1 POUCHTABLET, FILM COATED15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN2572ed69-d5a7-4513-a202-aca3230e7ec55
197806ibuprofen 600 MG Oral TabletSCD2572ed69-d5a7-4513-a202-aca3230e7ec55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2902-07051829020030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2902-0) 2020-10-060000-00-00NoNoCurrent
70518-2902-17051829020150 POUCH in 1 BOX (70518-2902-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-2902-2) 50 pouch2026-04-23NoNoHistorical
70518-2902-2705182902021 in 1 POUCHHistorical