FDA.reportPublic FDA data

Ibuprofen 200 mg

Product NDC
69168-368
11-digit product format
691680368
Labeler code
69168
Product ID
69168-368_2384fd3b-de52-46c9-bea9-4d8a0342fe59
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Allegiant Health
Application
ANDA079205
Marketing category
ANDA
Marketing start
2014-12-22
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 200 mg
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
69168-368-07Ibuprofen 200 mg1 in 1 CARTONCAPSULE, LIQUID FILLED12
69168-368-07Ibuprofen 200 mg10 in 1 BOTTLECAPSULE, LIQUID FILLED102
69168-368-30Ibuprofen 200 mg1 in 1 CARTONCAPSULE, LIQUID FILLED12
69168-368-30Ibuprofen 200 mg30 in 1 BOTTLECAPSULE, LIQUID FILLED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-368IBUPROFEN 200 MG (IBUPROFEN) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]2Current NDC, Legacy NDC, 4 package rows20220610_8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad2
310964ibuprofen 200 MG Oral CapsuleSCD8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-368-07691680368071 BOTTLE in 1 CARTON (69168-368-07) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2014-12-220000-00-00NoNoCurrent
69168-368-30691680368301 BOTTLE in 1 CARTON (69168-368-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2014-12-220000-00-00NoNoCurrent