FDA.reportPublic FDA data

Childrens Ibuprofen Oral Suspension

Product NDC
0121-0914
11-digit product format
001210914
Labeler code
0121
Product ID
0121-0914_e78c2544-9dfe-6399-e053-2995a90ac3d0
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA074916
Marketing category
ANDA
Marketing start
1999-04-30
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
0121-0914-00Childrens Ibuprofen Oral Suspension10 in 1 TRAYSUSPENSION105
0121-0914-00Childrens Ibuprofen Oral Suspension10 in 1 CASESUSPENSION105
0121-0914-05Childrens Ibuprofen Oral Suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0914-00ML - Milliliter0121-0914672c74ba-f41e-4e62-890d-bd98f5e0dd0f12020-08-06
0121-0914-05ML - Milliliter0121-09142a3f142d-5657-4a2a-afce-0c051390796c12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0914CHILDRENS IBUPROFEN ORAL SUSPENSION (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]5Current NDC, Legacy NDC, 3 package rows20220901_7a6832f2-2d80-483c-bde3-e6cacb7c318a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN7a6832f2-2d80-483c-bde3-e6cacb7c318a5
197803ibuprofen 20 MG/ML Oral SuspensionSCD7a6832f2-2d80-483c-bde3-e6cacb7c318a5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY7a6832f2-2d80-483c-bde3-e6cacb7c318a5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY7a6832f2-2d80-483c-bde3-e6cacb7c318a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0914-000012109140010 TRAY in 1 CASE (0121-0914-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0914-05) 10 tray2020-06-180000-00-00NoNoCurrent
0121-0914-05001210914055 mL in 1 CUP, UNIT-DOSE5 mlHistorical