ibuprofen

Product NDC
0363-0897
11-digit product format
003630897
Labeler code
0363
Product ID
0363-0897_a0ff1a01-4914-42c9-b837-754885a75f7a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
1999-03-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ibuprofen
Brand name suffix
childrens
Listing expiration
2027-12-31

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
0363-0897-26ibuprofenchildrens1 in 1 CARTONSUSPENSION110
0363-0897-26ibuprofenchildrens120 mL in 1 BOTTLESUSPENSION12010
0363-0897-28ibuprofenchildrens148 mL in 1 BOTTLESUSPENSION14810
0363-0897-28ibuprofenchildrens1 in 1 CARTONSUSPENSION110
0363-0897-34ibuprofenchildrens240 mL in 1 BOTTLESUSPENSION24010
0363-0897-34ibuprofenchildrens1 in 1 CARTONSUSPENSION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0897-26ML - Milliliter0363-08972e400868-d8e4-4239-92ac-36b64c93270812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0897IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [WALGREEN COMPANY]9Current NDC, Legacy NDC, 6 package rows20231012_f67612e8-38f3-4d1c-889b-57995a2f9f66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNf67612e8-38f3-4d1c-889b-57995a2f9f6610
197803ibuprofen 20 MG/ML Oral SuspensionSCDf67612e8-38f3-4d1c-889b-57995a2f9f6610
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYf67612e8-38f3-4d1c-889b-57995a2f9f6610
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYf67612e8-38f3-4d1c-889b-57995a2f9f6610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0897-26003630897261 BOTTLE in 1 CARTON (0363-0897-26) / 120 mL in 1 BOTTLE1 bottle1999-03-110000-00-00NoNoCurrent
0363-0897-28003630897281 BOTTLE in 1 CARTON (0363-0897-28) > 148 mL in 1 BOTTLE1 bottle2013-09-280000-00-00NoNoCurrent
0363-0897-34003630897341 BOTTLE in 1 CARTON (0363-0897-34) / 240 mL in 1 BOTTLE1 bottle2008-01-292026-08-31NoNoCurrent