FDA.reportPublic FDA data

Ibuprofen

Product NDC
63868-470
11-digit product format
638680470
Labeler code
63868
Product ID
63868-470_f0d3a221-4870-abc3-e053-2995a90aa4be
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA078682
Marketing category
ANDA
Marketing start
2019-10-09
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
63868-470-20Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED202
63868-470-20Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED12
63868-470-48Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED12
63868-470-48Ibuprofen48 in 1 BOTTLECAPSULE, LIQUID FILLED482
63868-470-80Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED802
63868-470-80Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-470-20EA - Each63868-47040b3a0db-3b30-435c-9ca3-1afa5ca82afe12022-10-06
63868-470-48EA - Each63868-47084a9505f-558a-457d-88c7-dbe04d20d10612022-10-06
63868-470-80EA - Each63868-470138aae0e-73fc-429b-ad33-4792d483ba7d12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-470IBUPROFEN CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, Legacy NDC, 6 package rows20221228_553d16e1-928e-4919-bc53-6683a035e2b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN553d16e1-928e-4919-bc53-6683a035e2b02
310964ibuprofen 200 MG Oral CapsuleSCD553d16e1-928e-4919-bc53-6683a035e2b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-470-20638680470201 BOTTLE in 1 CARTON (63868-470-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-10-090000-00-00NoNoCurrent
63868-470-48638680470481 BOTTLE in 1 CARTON (63868-470-48) / 48 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-10-090000-00-00NoNoCurrent
63868-470-80638680470801 BOTTLE in 1 CARTON (63868-470-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-10-090000-00-00NoNoCurrent