FDA.reportPublic FDA data

COMBOGESIC IV

Product NDC
0143-9150
11-digit product format
001439150
Labeler code
0143
Product ID
0143-9150_8438b258-011d-4734-86f7-be0334c9db34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and ibuprofen injection
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA215320
Marketing category
NDA
Marketing start
2024-02-05
Substance
ACETAMINOPHEN; IBUPROFEN
Active strength
1000; 300 mg/100mL; mg/100mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COMBOGESIC IV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/100mL
IBUPROFEN300 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2673874, 2673880

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
0143-9150-01COMBOGESIC IV100 mL in 1 VIALINJECTION1005
0143-9150-10COMBOGESIC IV10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9150-01ML - Milliliter0143-9150d37cb79f-d97e-4b29-b379-877624c3a16a12024-02-14
0143-9150-10ML - Milliliter0143-9150238ef363-e14c-4a25-8da1-9bcd3130a0bc12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9150COMBOGESIC IV (ACETAMINOPHEN AND IBUPROFEN INJECTION) INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20240508_be408a5a-48e4-43c0-9cb1-bbf830b54f5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2673874acetaminophen 1000 MG / ibuprofen 300 MG in 100 ML InjectionPSNbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5
2673880combogesic IV 1000 MG / 300 MG in 100 ML InjectionPSNbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5
2673880100 ML acetaminophen 10 MG/ML / ibuprofen 3 MG/ML Injection [Combogesic]SBDbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5
2673874100 ML acetaminophen 10 MG/ML / ibuprofen 3 MG/ML InjectionSCDbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5
2673874100 ML APAP 10 MG/ML / ibuprofen 3 MG/ML InjectionSYbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5
2673880100 ML APAP 10 MG/ML / ibuprofen 3 MG/ML Injection [Combogesic]SYbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5
2673874acetaminophen 1000 MG / ibuprofen 300 MG per 100 ML InjectionSYbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5
2673880Combogesic IV (acetaminophen 1000 MG / ibuprofen 300 MG per 100 ML) InjectionSYbe408a5a-48e4-43c0-9cb1-bbf830b54f5b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9150-0100143915001100 mL in 1 VIAL100 mlHistorical
0143-9150-100014391501010 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01) 10 vial2024-02-05NoNoCurrent