FDA.reportPublic FDA data

Ibuprofen

Product NDC
0904-5309
11-digit product format
009045309
Labeler code
0904
Product ID
0904-5309_d07b6a1b-1390-466f-8cfd-95e809f8044c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA074937
Marketing category
ANDA
Marketing start
1999-02-07
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
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5309-09Ibuprofen240 mL in 1 BOTTLESUSPENSION2409
0904-5309-09Ibuprofen1 in 1 CARTONSUSPENSION19
0904-5309-20Ibuprofen120 mL in 1 BOTTLESUSPENSION1209
0904-5309-20Ibuprofen1 in 1 CARTONSUSPENSION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5309-09ML - Milliliter0904-530984c04695-1074-42e6-acd5-1135fa49faa912012-07-24
0904-5309-20ML - Milliliter0904-53098ae6ee02-bad4-4150-bfb7-98614da02dd712013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5309IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 4 package rows20250305_847758ed-66fc-4db9-8fdb-78f3c3291a03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN230914e6-fe0c-45be-8b2e-e066c71d004c12
197803ibuprofen 20 MG/ML Oral SuspensionSCD230914e6-fe0c-45be-8b2e-e066c71d004c12
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY230914e6-fe0c-45be-8b2e-e066c71d004c12
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY230914e6-fe0c-45be-8b2e-e066c71d004c12
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN847758ed-66fc-4db9-8fdb-78f3c3291a039
197803ibuprofen 20 MG/ML Oral SuspensionSCD847758ed-66fc-4db9-8fdb-78f3c3291a039
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY847758ed-66fc-4db9-8fdb-78f3c3291a039
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY847758ed-66fc-4db9-8fdb-78f3c3291a039
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN707a0325-fa88-4b3a-a5fd-10696882081e5
197803ibuprofen 20 MG/ML Oral SuspensionSCD707a0325-fa88-4b3a-a5fd-10696882081e5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY707a0325-fa88-4b3a-a5fd-10696882081e5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY707a0325-fa88-4b3a-a5fd-10696882081e5
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN3ce7549f-e4db-9f89-e063-6294a90a126d1
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNd04a5ea0-0acd-4aaf-8d60-a6b08f3c04a81
197803ibuprofen 20 MG/ML Oral SuspensionSCD3ce7549f-e4db-9f89-e063-6294a90a126d1
197803ibuprofen 20 MG/ML Oral SuspensionSCDd04a5ea0-0acd-4aaf-8d60-a6b08f3c04a81
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY3ce7549f-e4db-9f89-e063-6294a90a126d1
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYd04a5ea0-0acd-4aaf-8d60-a6b08f3c04a81
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY3ce7549f-e4db-9f89-e063-6294a90a126d1
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYd04a5ea0-0acd-4aaf-8d60-a6b08f3c04a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5309-09009045309091 BOTTLE in 1 CARTON (0904-5309-09) / 240 mL in 1 BOTTLE1 bottle2003-12-090000-00-00NoNoCurrent
0904-5309-20009045309201 BOTTLE in 1 CARTON (0904-5309-20) / 120 mL in 1 BOTTLE1 bottle1999-02-070000-00-00NoNoCurrent