FDA.reportPublic FDA data

Ibuprofen

Product NDC
51672-1385
11-digit product format
516721385
Labeler code
51672
Product ID
51672-1385_46f3c164-da78-0045-e063-6294a90a6885
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA209204
Marketing category
ANDA
Marketing start
2017-06-23
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
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
51672-1385-8Ibuprofen1 in 1 CARTONSUSPENSION18
51672-1385-8Ibuprofen118 mL in 1 BOTTLESUSPENSION1188
51672-1385-9Ibuprofen473 mL in 1 BOTTLESUSPENSION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1385-8ML - Milliliter51672-138513a2a3e8-f834-4d2d-a6b8-b343115b264c12017-10-13
51672-1385-9ML - Milliliter51672-13857c8f4189-f5ee-4e29-8c05-9539e9dfe33f12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1385IBUPROFEN SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 3 package rows20250406_a8b46ae5-67bc-494d-850e-b4e4ed5a33b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNa8b46ae5-67bc-494d-850e-b4e4ed5a33b38
197803ibuprofen 20 MG/ML Oral SuspensionSCDa8b46ae5-67bc-494d-850e-b4e4ed5a33b38
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYa8b46ae5-67bc-494d-850e-b4e4ed5a33b38
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYa8b46ae5-67bc-494d-850e-b4e4ed5a33b38
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNdda7645f-1666-4c1f-b974-01add2ea79ac1
197803ibuprofen 20 MG/ML Oral SuspensionSCDdda7645f-1666-4c1f-b974-01add2ea79ac1
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYdda7645f-1666-4c1f-b974-01add2ea79ac1
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYdda7645f-1666-4c1f-b974-01add2ea79ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1385-8516721385081 BOTTLE in 1 CARTON (51672-1385-8) / 118 mL in 1 BOTTLE1 bottle2017-06-230000-00-00NoNoCurrent
51672-1385-951672138509473 mL in 1 BOTTLE (51672-1385-9) 473 ml2017-06-230000-00-00NoNoCurrent