Ibuprofen

Product NDC
59556-876
11-digit product format
595560876
Labeler code
59556
Product ID
59556-876_4cd77671-6091-4bd0-9a34-8650001b9fdd
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA211666
Marketing category
ANDA
Marketing start
2022-02-21
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
59556-876-01Ibuprofen1 in 1 CARTONSUSPENSION14
59556-876-01Ibuprofen240 mL in 1 BOTTLE, PLASTICSUSPENSION2404
59556-876-72Ibuprofen1 in 1 CARTONSUSPENSION14
59556-876-72Ibuprofen120 mL in 1 BOTTLE, PLASTICSUSPENSION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-876IBUPROFEN SUSPENSION [STRIDES PHARMA INC]4Legacy NDC, 4 package rows20250325_c3c600dd-6eec-4304-868e-9642de5e1dac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNc3c600dd-6eec-4304-868e-9642de5e1dac4
197803ibuprofen 20 MG/ML Oral SuspensionSCDc3c600dd-6eec-4304-868e-9642de5e1dac4
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYc3c600dd-6eec-4304-868e-9642de5e1dac4
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYc3c600dd-6eec-4304-868e-9642de5e1dac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59556-876-01595560876011 in 1 CARTONHistorical
59556-876-72595560876721 BOTTLE, PLASTIC in 1 CARTON (59556-876-72) > 120 mL in 1 BOTTLE, PLASTIC2022-02-210000-00-00NoNoCurrent