FDA.reportPublic FDA data

Ibuprofen

Product NDC
55910-399
11-digit product format
559100399
Labeler code
55910
Product ID
55910-399_e177a580-dbcd-6a37-e053-2995a90a6fb8
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
DOLGENCORP, INC.
Application
ANDA079205
Marketing category
ANDA
Marketing start
2022-07-12
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
55910-399-12Ibuprofen120 in 1 BOTTLECAPSULE, LIQUID FILLED1202
55910-399-20Ibuprofen200 in 1 BOTTLECAPSULE, LIQUID FILLED2002
55910-399-23Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED202
55910-399-23Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED12
55910-399-80Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED802
55910-399-80Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-399IBUPROFEN CAPSULE, LIQUID FILLED [DOLGENCORP, INC.]2Current NDC, Legacy NDC, 6 package rows20220712_df321783-73cb-55bf-e053-2a95a90a4ce2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNdf321783-73cb-55bf-e053-2a95a90a4ce22
310964ibuprofen 200 MG Oral CapsuleSCDdf321783-73cb-55bf-e053-2a95a90a4ce22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-399-1255910039912120 CAPSULE, LIQUID FILLED in 1 BOTTLE (55910-399-12) 2022-07-120000-00-00NoNoCurrent
55910-399-2055910039920200 CAPSULE, LIQUID FILLED in 1 BOTTLE (55910-399-20) 2022-07-120000-00-00NoNoCurrent
55910-399-23559100399231 BOTTLE in 1 CARTON (55910-399-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-07-120000-00-00NoNoCurrent
55910-399-80559100399801 BOTTLE in 1 CARTON (55910-399-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-07-120000-00-00NoNoCurrent