IBUPROFEN

Product NDC
0363-1610
11-digit product format
003631610
Labeler code
0363
Product ID
0363-1610_13af6333-7380-e54c-e063-6294a90aaa35
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALGREENS
Application
ANDA079205
Marketing category
ANDA
Marketing start
2016-01-27
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1610-23IBUPROFEN20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED204
0363-1610-31IBUPROFEN300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3004
0363-1610-44IBUPROFEN40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED404
0363-1610-66IBUPROFEN160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1604
0363-1610-80IBUPROFEN80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1610-23EA - Each0363-16106953475b-6bd7-4e19-ad2d-9616384a76c312022-06-06
0363-1610-31EA - Each0363-1610b549774f-eefa-4ed9-aae9-f14b4a4ab65b12022-06-06
0363-1610-44EA - Each0363-1610fc8af483-493f-47a3-907b-5ded6e8e49ba12022-06-06
0363-1610-66EA - Each0363-161023edadc2-b052-4ca9-b7e8-eda506df5e8112022-06-06
0363-1610-80EA - Each0363-161072fec919-d9ee-4711-b317-eff8707bc90c12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1610IBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]4Current NDC, Legacy NDC, 5 package rows20240316_3ce5b71b-f841-444f-bf66-023e4bd9aa16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN3ce5b71b-f841-444f-bf66-023e4bd9aa164
310964ibuprofen 200 MG Oral CapsuleSCD3ce5b71b-f841-444f-bf66-023e4bd9aa164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-1610-230036316102320 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-1610-23) 2016-01-270000-00-00NoNoCurrent
0363-1610-3100363161031300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-1610-31) 2016-01-270000-00-00NoNoCurrent
0363-1610-440036316104440 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-1610-44) 2016-01-270000-00-00NoNoCurrent
0363-1610-6600363161066160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-1610-66) 2016-01-270000-00-00NoNoCurrent
0363-1610-800036316108080 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-1610-80) 2016-01-270000-00-00NoNoCurrent