FDA.reportPublic FDA data

Childrens Ibuprofen Oral Suspension

Product NDC
0121-0833
11-digit product format
001210833
Labeler code
0121
Product ID
0121-0833_70b3589f-fd88-4a73-b758-0d456422bd27
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA214789
Marketing category
ANDA
Marketing start
2025-08-01
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Ibuprofen Oral Suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
0121-0833-00Childrens Ibuprofen Oral Suspension10 in 1 CASESUSPENSION108
0121-0833-00Childrens Ibuprofen Oral Suspension10 in 1 TRAYSUSPENSION108
0121-0833-05Childrens Ibuprofen Oral Suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION58
0121-0833-40Childrens Ibuprofen Oral Suspension4 in 1 CASESUSPENSION48
0121-0833-40Childrens Ibuprofen Oral Suspension10 in 1 TRAYSUSPENSION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0833-00ML - Milliliter0121-0833a218cb62-b428-4e73-b9b8-7cd61bef15ab12025-08-11
0121-0833-05ML - Milliliter0121-0833588c5ecb-1f31-40b7-87f7-84cc769cea3412025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0833CHILDRENS IBUPROFEN ORAL SUSPENSION (IBUPROFEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]5Current NDC, 5 package rows20250507_c26cefe0-182a-4b03-baeb-b3eb2e0e2267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNc26cefe0-182a-4b03-baeb-b3eb2e0e22678
197803ibuprofen 20 MG/ML Oral SuspensionSCDc26cefe0-182a-4b03-baeb-b3eb2e0e22678
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYc26cefe0-182a-4b03-baeb-b3eb2e0e22678
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYc26cefe0-182a-4b03-baeb-b3eb2e0e22678

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-0833-000012108330010 TRAY in 1 CASE (0121-0833-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05) 10 tray2025-08-01NoNoHistorical
0121-0833-05001210833055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0833-40001210833404 TRAY in 1 CASE (0121-0833-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05) 4 tray2025-08-01NoNoHistorical