FDA.reportPublic FDA data

ibuprofen

Product NDC
51672-5321
11-digit product format
516725321
Labeler code
51672
Product ID
51672-5321_b7b5ccd2-1de9-4b93-b2bb-09bc540704fd
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
TARO PHARMACEUTICALS U.S.A., INC.
Application
ANDA211666
Marketing category
ANDA
Marketing start
2024-08-15
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
51672-5321-1ibuprofen240 mL in 1 BOTTLE, PLASTICSUSPENSION2402
51672-5321-1ibuprofen1 in 1 CARTONSUSPENSION12
51672-5321-8ibuprofen1 in 1 CARTONSUSPENSION12
51672-5321-8ibuprofen120 mL in 1 BOTTLE, PLASTICSUSPENSION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5321-8ML - Milliliter51672-53213223b3f8-fa6d-4b6a-bcc8-3189b267902912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5321IBUPROFEN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, 4 package rows20250315_9de61620-6750-4fb6-89a4-fe451ab8d99f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN9de61620-6750-4fb6-89a4-fe451ab8d99f2
197803ibuprofen 20 MG/ML Oral SuspensionSCD7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 20 MG/ML Oral SuspensionSCD9de61620-6750-4fb6-89a4-fe451ab8d99f2
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY9de61620-6750-4fb6-89a4-fe451ab8d99f2
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY9de61620-6750-4fb6-89a4-fe451ab8d99f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51672-5321-1516725321011 BOTTLE, PLASTIC in 1 CARTON (51672-5321-1) / 240 mL in 1 BOTTLE, PLASTIC2024-10-10NoNoHistorical
51672-5321-8516725321081 BOTTLE, PLASTIC in 1 CARTON (51672-5321-8) / 120 mL in 1 BOTTLE, PLASTIC2024-08-15NoNoHistorical