FDA.reportPublic FDA data

ibuprofen

Product NDC
30142-166
11-digit product format
301420166
Labeler code
30142
Product ID
30142-166_aa9320f1-068f-4253-88ef-4113a6719194
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kroger Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
2002-11-20
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
2023-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-166-262026-01-29C16284748780-149896155-a998-586f-e063-e6dba90add90Kroger Co. Children’s Ibuprofen Drug Facts
30142-166-282026-01-29C16284748780-149896155-a998-586f-e063-e6dba90add90Kroger Co. Children’s Ibuprofen Drug Facts
30142-166-342026-01-29C16284748780-149896155-a998-586f-e063-e6dba90add90Kroger Co. Children’s Ibuprofen Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-166-26ibuprofen1 in 1 CARTONSUSPENSION19
30142-166-26ibuprofen118 mL in 1 BOTTLESUSPENSION1189
30142-166-28ibuprofen147 mL in 1 BOTTLESUSPENSION1479
30142-166-28ibuprofen1 in 1 CARTONSUSPENSION19
30142-166-34ibuprofen240 mL in 1 BOTTLESUSPENSION2409
30142-166-34ibuprofen1 in 1 CARTONSUSPENSION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-166IBUPROFEN SUSPENSION [KROGER COMPANY]9Legacy NDC, 6 package rows20221105_1344a190-c331-490d-9df7-8a5ef6d52ad9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN1344a190-c331-490d-9df7-8a5ef6d52ad99
197803ibuprofen 20 MG/ML Oral SuspensionSCD1344a190-c331-490d-9df7-8a5ef6d52ad99
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY1344a190-c331-490d-9df7-8a5ef6d52ad99
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY1344a190-c331-490d-9df7-8a5ef6d52ad99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-166-26301420166261 BOTTLE in 1 CARTON (30142-166-26) > 118 mL in 1 BOTTLE1 bottle2002-11-200000-00-00NoNoCurrent
30142-166-28301420166281 BOTTLE in 1 CARTON (30142-166-28) > 147 mL in 1 BOTTLE1 bottle2013-09-040000-00-00NoNoCurrent
30142-166-34301420166341 BOTTLE in 1 CARTON (30142-166-34) > 240 mL in 1 BOTTLE1 bottle2008-03-280000-00-00NoNoCurrent