Ibuprofen

Product NDC
68016-813
11-digit product format
680160813
Labeler code
68016
Product ID
68016-813_69ce712e-0024-4d6c-8cff-a2601d06ebef
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA206568
Marketing category
ANDA
Marketing start
2022-08-26
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

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
68016-813-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED402
68016-813-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-813IBUPROFEN CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]1Current NDC, Legacy NDC, 2 package rows20220904_f0f01b97-e52c-4077-a4c6-c59736f4c171.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNf0f01b97-e52c-4077-a4c6-c59736f4c1712
310964ibuprofen 200 MG Oral CapsuleSCDf0f01b97-e52c-4077-a4c6-c59736f4c1712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-813-40680160813401 BOTTLE, PLASTIC in 1 BOX (68016-813-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2022-08-262026-12-31NoNoCurrent