FDA.reportPublic FDA data

Ibuprofen

Product NDC
0363-0945
11-digit product format
003630945
Labeler code
0363
Product ID
0363-0945_fafa750f-5cc0-4f13-a808-d63b3d6e7008
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
ANDA206568
Marketing category
ANDA
Marketing start
2018-01-31
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
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
0363-0945-16Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1605
0363-0945-16Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
0363-0945-20Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED205
0363-0945-20Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
0363-0945-30Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3005
0363-0945-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED405
0363-0945-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
0363-0945-80Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED15
0363-0945-80Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0945-16EA - Each0363-0945619d2378-2072-45b9-bfd7-6ad3dc0f5e7912022-06-06
0363-0945-20EA - Each0363-0945cda13fb2-2817-464d-8088-b7fb7915c55e12022-06-06
0363-0945-40EA - Each0363-0945c2b8c936-e352-4324-a9f2-dca67ea9abf312022-06-06
0363-0945-80EA - Each0363-0945575eb237-de0b-47f4-a6c5-2b98743ea4d012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0945IBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]5Current NDC, Legacy NDC, 9 package rows20221201_6bd8a0c2-314f-47cb-80cd-1d4dd92b209f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN6bd8a0c2-314f-47cb-80cd-1d4dd92b209f5
310964ibuprofen 200 MG Oral CapsuleSCD6bd8a0c2-314f-47cb-80cd-1d4dd92b209f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0945-16003630945161 BOTTLE, PLASTIC in 1 BOX (0363-0945-16) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent
0363-0945-20003630945201 BOTTLE, PLASTIC in 1 BOX (0363-0945-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent
0363-0945-3000363094530300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0945-30) 2018-01-310000-00-00NoNoCurrent
0363-0945-40003630945401 BOTTLE, PLASTIC in 1 BOX (0363-0945-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent
0363-0945-80003630945801 BOTTLE, PLASTIC in 1 BOX (0363-0945-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent