FDA.reportPublic FDA data

Ibuprofen

Product NDC
0363-0221
11-digit product format
003630221
Labeler code
0363
Product ID
0363-0221_f0e93c45-051d-7362-e053-2a95a90a0cb2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALGREEN COMPANY
Application
ANDA078682
Marketing category
ANDA
Marketing start
2019-08-02
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
0363-0221-11Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED203
0363-0221-11Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
0363-0221-15Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED403
0363-0221-15Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
0363-0221-78Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
0363-0221-78Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED803
0363-0221-79Ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1603
0363-0221-79Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
0363-0221-83Ibuprofen300 in 1 BOTTLECAPSULE, LIQUID FILLED3003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0221-11EA - Each0363-0221b38f7b77-ffed-47df-a9b7-c20df9c684c412022-06-06
0363-0221-15EA - Each0363-022147e78eba-229b-4da3-9495-06f428f9dc0812022-06-06
0363-0221-78EA - Each0363-022162bc1d2a-bf4a-4b77-b4a3-66a55672a44712022-06-06
0363-0221-79EA - Each0363-02215d9eca81-ef66-4000-a31f-93231c468d9912022-06-06
0363-0221-83EA - Each0363-0221df8c5985-cdcc-4239-82dd-5b0eb5ece2e612022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0221IBUPROFEN CAPSULE, LIQUID FILLED [WALGREEN COMPANY]3Current NDC, Legacy NDC, 9 package rows20221229_4ce20d2b-2dfb-4405-b545-dd1f67b2c588.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN4ce20d2b-2dfb-4405-b545-dd1f67b2c5883
310964ibuprofen 200 MG Oral CapsuleSCD4ce20d2b-2dfb-4405-b545-dd1f67b2c5883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0221-11003630221111 BOTTLE in 1 CARTON (0363-0221-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-08-020000-00-00NoNoCurrent
0363-0221-15003630221151 BOTTLE in 1 CARTON (0363-0221-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-08-020000-00-00NoNoCurrent
0363-0221-78003630221781 BOTTLE in 1 CARTON (0363-0221-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-08-020000-00-00NoNoCurrent
0363-0221-79003630221791 BOTTLE in 1 CARTON (0363-0221-79) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-08-020000-00-00NoNoCurrent
0363-0221-8300363022183300 CAPSULE, LIQUID FILLED in 1 BOTTLE (0363-0221-83) 2019-08-020000-00-00NoNoCurrent