FDA.reportPublic FDA data

Ibuprofen

Product NDC
55910-518
11-digit product format
559100518
Labeler code
55910
Product ID
55910-518_36204b38-c646-3f83-e063-6294a90a6977
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
DOLGENCORP INC
Application
ANDA078682
Marketing category
ANDA
Marketing start
2023-10-26
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-518-11Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
55910-518-11Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED203
55910-518-15Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
55910-518-15Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED403
55910-518-22Ibuprofen120 in 1 BOTTLECAPSULE, LIQUID FILLED1203
55910-518-26Ibuprofen200 in 1 BOTTLECAPSULE, LIQUID FILLED2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-518IBUPROFEN CAPSULE, LIQUID FILLED [DOLGENCORP INC]3Current NDC, 6 package rows20250529_03138a6f-653a-f359-e063-6394a90ac5d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN03138a6f-653a-f359-e063-6394a90ac5d63
310964ibuprofen 200 MG Oral CapsuleSCD03138a6f-653a-f359-e063-6394a90ac5d63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-518-11559100518111 BOTTLE in 1 CARTON (55910-518-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-10-26NoNoCurrent
55910-518-15559100518151 BOTTLE in 1 CARTON (55910-518-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-10-26NoNoCurrent
55910-518-2255910051822120 CAPSULE, LIQUID FILLED in 1 BOTTLE (55910-518-22) 2023-10-26NoNoCurrent
55910-518-2655910051826200 CAPSULE, LIQUID FILLED in 1 BOTTLE (55910-518-26) 2023-10-26NoNoCurrent