FDA.reportPublic FDA data

Dye-Free Ibuprofen

Product NDC
63868-805
11-digit product format
638680805
Labeler code
63868
Product ID
63868-805_f0d274bd-b6b5-74c9-e053-2995a90a6f72
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
2021-11-16
Substance
IBUPROFEN
Active strength
200 mg/1201
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
Dye-Free Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1201

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
63868-805-40Dye-Free Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED12
63868-805-40Dye-Free Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-805-40EA - Each63868-8051f7a05c7-5280-4ef2-9c3e-78ef93e6e88812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-805DYE-FREE IBUPROFEN (IBUPROFEN) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, Legacy NDC, 2 package rows20221228_d0eff659-6445-a56a-e053-2995a90a72e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNd0eff659-6445-a56a-e053-2995a90a72e92
310964ibuprofen 200 MG Oral CapsuleSCDd0eff659-6445-a56a-e053-2995a90a72e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-805-40638680805401 BOTTLE in 1 CARTON (63868-805-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-11-160000-00-00NoNoCurrent