FDA.reportPublic FDA data

Ibuprofen

Product NDC
0472-2002
11-digit product format
004722002
Labeler code
0472
Product ID
0472-2002_2e9a1263-be1c-4fa3-8108-0a634fec2593
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074978
Marketing category
ANDA
Marketing start
2018-07-16
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
Ibuprofen
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0472-2002-16Ibuprofen473 mL in 1 BOTTLESUSPENSION47316
0472-2002-94Ibuprofen1 in 1 CARTONSUSPENSION116
0472-2002-94Ibuprofen118 mL in 1 BOTTLESUSPENSION11816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-2002-16ML - Milliliter0472-200252acd4c8-c07e-41c5-b3f6-417f2569ae5112018-08-13
0472-2002-94ML - Milliliter0472-200254b608f5-5867-4a7f-b640-185276fb95e412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-2002IBUPROFEN SUSPENSION [ACTAVIS PHARMA, INC.]16Current NDC, Legacy NDC, 3 package rows20241215_3d156d13-25d8-4cfc-8285-5f7ebf48cf45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN3d156d13-25d8-4cfc-8285-5f7ebf48cf4516
197803ibuprofen 20 MG/ML Oral SuspensionSCD3d156d13-25d8-4cfc-8285-5f7ebf48cf4516
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY3d156d13-25d8-4cfc-8285-5f7ebf48cf4516
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY3d156d13-25d8-4cfc-8285-5f7ebf48cf4516
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN72b32512-05c7-4113-b0cc-de9c97de2abb1
197803ibuprofen 20 MG/ML Oral SuspensionSCD72b32512-05c7-4113-b0cc-de9c97de2abb1
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY72b32512-05c7-4113-b0cc-de9c97de2abb1
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY72b32512-05c7-4113-b0cc-de9c97de2abb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-2002-1600472200216473 mL in 1 BOTTLE (0472-2002-16) 473 ml2018-07-160000-00-00NoNoCurrent
0472-2002-94004722002941 BOTTLE in 1 CARTON (0472-2002-94) / 118 mL in 1 BOTTLE1 bottle2018-08-140000-00-00NoNoCurrent