FDA.reportPublic FDA data

Ibuprofen minis

Product NDC
0363-0743
11-digit product format
003630743
Labeler code
0363
Product ID
0363-0743_1133a148-7507-4b45-bf51-15821696016d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
ANDA206568
Marketing category
ANDA
Marketing start
2019-03-31
Marketing end
2027-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen minis

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
0363-0743-20Ibuprofen minis1 in 1 BOXCAPSULE, LIQUID FILLED19
0363-0743-20Ibuprofen minis20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED209
0363-0743-80Ibuprofen minis80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED809
0363-0743-80Ibuprofen minis1 in 1 BOXCAPSULE, LIQUID FILLED19
0363-0743-96Ibuprofen minis96 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED969
0363-0743-96Ibuprofen minis1 in 1 BOXCAPSULE, LIQUID FILLED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0743IBUPROFEN MINIS (IBUPROFEN) CAPSULE, LIQUID FILLED [WALGREENS]8Current NDC, Legacy NDC, 6 package rows20241105_6d1d131d-0741-4a75-8383-9322f4f3faab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN6d1d131d-0741-4a75-8383-9322f4f3faab9
310964ibuprofen 200 MG Oral CapsuleSCD6d1d131d-0741-4a75-8383-9322f4f3faab9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0743-20003630743201 BOTTLE, PLASTIC in 1 BOX (0363-0743-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-03-312027-12-31NoNoCurrent
0363-0743-80003630743801 BOTTLE, PLASTIC in 1 BOX (0363-0743-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-03-312027-12-31NoNoCurrent
0363-0743-96003630743961 BOTTLE, PLASTIC in 1 BOX (0363-0743-96) / 96 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-03-312027-12-31NoNoHistorical