FDA.reportPublic FDA data

Combogesic

Product NDC
0143-9432
11-digit product format
001439432
Labeler code
0143
Product ID
0143-9432_186821ca-5ce7-403e-9470-39f6691cd492
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAMINOPHEN and IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc
Application
NDA209471
Marketing category
NDA
Marketing start
2025-01-06
Substance
ACETAMINOPHEN; IBUPROFEN
Active strength
325; 97.5 mg/1; 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
Combogesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
IBUPROFEN97.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2675760, 2675765

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
0143-9432-27Combogesic250 in 1 BOTTLE, PLASTICTABLET, FILM COATED2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9432COMBOGESIC (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC]3Current NDC, 1 package rows20250116_b32651c4-7fa0-415b-91eb-854aa1c28f2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675760acetaminophen 325 MG / ibuprofen 97.5 MG Oral TabletPSNb32651c4-7fa0-415b-91eb-854aa1c28f2a3
2675765combogesic 325 MG / 97.5 MG Oral TabletPSNb32651c4-7fa0-415b-91eb-854aa1c28f2a3
2675765acetaminophen 325 MG / ibuprofen 97.5 MG Oral Tablet [Combogesic]SBDb32651c4-7fa0-415b-91eb-854aa1c28f2a3
2675760acetaminophen 325 MG / ibuprofen 97.5 MG Oral TabletSCDb32651c4-7fa0-415b-91eb-854aa1c28f2a3
2675760acetaminophen 325 MG / ibuprofen 97.5 MG Oral TabletSYb32651c4-7fa0-415b-91eb-854aa1c28f2a3
2675760APAP 325 MG / ibuprofen 97.5 MG Oral TabletSYb32651c4-7fa0-415b-91eb-854aa1c28f2a3
2675765APAP 325 MG / ibuprofen 97.5 MG Oral Tablet [Combogesic]SYb32651c4-7fa0-415b-91eb-854aa1c28f2a3
2675765Combogesic 325 MG / 97.5 MG Oral TabletSYb32651c4-7fa0-415b-91eb-854aa1c28f2a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9432-2700143943227250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0143-9432-27) 2025-01-06NoNoHistorical