FDA.reportPublic FDA data

dg health ibuprofen

Product NDC
55910-758
11-digit product format
559100758
Labeler code
55910
Product ID
55910-758_cda56182-d0ac-4ab8-9f2c-996c5a66fe42
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA077349
Marketing category
ANDA
Marketing start
2022-05-03
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
dg health ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
55910-758-71dg health ibuprofen50 in 1 BOTTLETABLET, FILM COATED502
55910-758-71dg health ibuprofen1 in 1 CARTONTABLET, FILM COATED12
55910-758-78dg health ibuprofen1 in 1 CARTONTABLET, FILM COATED12
55910-758-78dg health ibuprofen100 in 1 BOTTLETABLET, FILM COATED1002
55910-758-85dg health ibuprofen250 in 1 BOTTLETABLET, FILM COATED2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-758DG HEALTH IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DOLGENCORP INC]2Current NDC, Legacy NDC, 5 package rows20240522_b514b589-d965-4a21-91b3-fab4019e9d96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNb514b589-d965-4a21-91b3-fab4019e9d962
310965ibuprofen 200 MG Oral TabletSCDb514b589-d965-4a21-91b3-fab4019e9d962
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYb514b589-d965-4a21-91b3-fab4019e9d962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-758-71559100758711 BOTTLE in 1 CARTON (55910-758-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-030000-00-00NoNoCurrent
55910-758-78559100758781 BOTTLE in 1 CARTON (55910-758-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-030000-00-00NoNoCurrent
55910-758-8555910075885250 TABLET, FILM COATED in 1 BOTTLE (55910-758-85) 2022-05-030000-00-00NoNoCurrent