Ibuprofen

Product NDC
11822-3061
11-digit product format
118223061
Labeler code
11822
Product ID
11822-3061_23163529-4bf4-464b-818b-db9b21a4eb13
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA074916
Marketing category
ANDA
Marketing start
2021-06-04
Marketing end
2026-06-04
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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
11822-3061-62023-10-31C16284748780-1f386c64a-05b2-0266-e053-dadaa90a7c1aIbuprofen Oral Suspension, USP
11822-3061-62023-01-30C16284748780-1f386c64a-05b2-0266-e053-dadaa90a7c1aIbuprofen Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3061-6IbuprofenChildrens118 mL in 1 BOTTLESUSPENSION1185
11822-3061-6IbuprofenChildrens1 in 1 BOXSUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3061IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]5Current NDC, Legacy NDC, 2 package rows20241109_cff88afe-45f1-44ed-ab92-89c0086aacd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNcff88afe-45f1-44ed-ab92-89c0086aacd05
197803ibuprofen 20 MG/ML Oral SuspensionSCDcff88afe-45f1-44ed-ab92-89c0086aacd05
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYcff88afe-45f1-44ed-ab92-89c0086aacd05
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYcff88afe-45f1-44ed-ab92-89c0086aacd05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3061-6118223061061 BOTTLE in 1 BOX (11822-3061-6) / 118 mL in 1 BOTTLE1 bottle2021-06-042026-06-04NoNoCurrent