FDA.reportPublic FDA data

Ibuprofen

Product NDC
63868-268
11-digit product format
638680268
Labeler code
63868
Product ID
63868-268_d07197cb-9b39-82f5-e053-2995a90a1e3b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA079174
Marketing category
ANDA
Marketing start
2021-05-31
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
Rxcui310965

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
63868-268-25Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, COATED2502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-268-25EA - Each63868-268dbe71690-3090-42f8-9e66-a371b6abe7d012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-268IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2Current NDC, Legacy NDC, 1 package rows20211111_c13455a3-307a-4fe1-e053-2a95a90adf8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNc13455a3-307a-4fe1-e053-2a95a90adf8e2
310965ibuprofen 200 MG Oral TabletSCDc13455a3-307a-4fe1-e053-2a95a90adf8e2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYc13455a3-307a-4fe1-e053-2a95a90adf8e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-268-2563868026825250 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-268-25) 2021-05-310000-00-00NoNoCurrent