FDA.reportPublic FDA data

Ibuprofen

Product NDC
41163-185
11-digit product format
411630185
Labeler code
41163
Product ID
41163-185_38de9d77-0739-3546-e063-6394a90a716a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA079205
Marketing category
ANDA
Marketing start
2018-01-01
Substance
IBUPROFEN
Active strength
200 mg/1
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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
41163-185-01Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
41163-185-01Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED205
41163-185-02Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
41163-185-02Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED405
41163-185-03Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED805
41163-185-03Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
41163-185-04Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1605
41163-185-06Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-185IBUPROFEN CAPSULE, LIQUID FILLED [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 8 package rows20230519_37eaa3b1-98e9-4fcf-ae74-153bfc35551f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN37eaa3b1-98e9-4fcf-ae74-153bfc35551f5
310964ibuprofen 200 MG Oral CapsuleSCD37eaa3b1-98e9-4fcf-ae74-153bfc35551f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-185-01411630185011 BOTTLE, PLASTIC in 1 CARTON (41163-185-01) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-010000-00-00NoNoCurrent
41163-185-02411630185021 BOTTLE, PLASTIC in 1 CARTON (41163-185-02) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-010000-00-00NoNoCurrent
41163-185-03411630185031 BOTTLE, PLASTIC in 1 CARTON (41163-185-03) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-010000-00-00NoNoCurrent
41163-185-0441163018504160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (41163-185-04) 2018-01-010000-00-00NoNoCurrent
41163-185-0641163018506300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (41163-185-06) 2018-01-010000-00-00NoNoCurrent