FDA.reportPublic FDA data

EMBLAVEO

Product NDC
0074-3878
11-digit product format
000743878
Labeler code
0074
Product ID
0074-3878_c35160ee-d73c-4288-8172-d69d75d52b1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aztreonam and avibactam
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
AbbVie Inc.
Application
NDA217906
Marketing category
NDA
Marketing start
2025-02-07
Substance
AVIBACTAM; AZTREONAM
Active strength
42.3; 127 mg/mL; mg/mL
Pharmacologic classes
Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZTREONAM42.3 mg/mL
AVIBACTAM127 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2B4VE5GH8, 7352665165
Rxcui2705355, 2705360

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
458b18b0-b105-44ac-b090-378873a4e07bProduct name120251118
882349af-ee4e-3057-6dd7-68d0b142db19Product name220220608
fb7d24f2-fcd1-4dc6-b9d0-b1f65bfffab5Product name120150409
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
74c5690d-3e83-e116-f1e7-47b67331bf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-3878-01EMBLAVEO12 mL in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION125
0074-3878-10EMBLAVEO10 in 1 CARTONPOWDER, FOR SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3878-01EA - Each0074-38788e57b4e9-2d4e-4f64-bd53-0486e75e0eb512025-06-13
0074-3878-10EA - Each0074-3878a2005170-50b6-463b-a847-d9a365b00a9612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3878EMBLAVEO (AZTREONAM AND AVIBACTAM) POWDER, FOR SOLUTION [ABBVIE INC.]3Current NDC, 2 package rows20250524_be1a6c99-d4b3-46d7-9e99-6e5f9fab556a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705355avibactam 0.5 GM / aztreonam 1.5 GM InjectionPSNbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5
2705360EMBLAVEO 0.5 GM / 1.5 GM InjectionPSNbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5
2705360avibactam 500 MG / aztreonam 1500 MG Injection [Emblaveo]SBDbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5
2705355avibactam 500 MG / aztreonam 1500 MG InjectionSCDbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5
2705355avibactam (as avibactam sodium) 0.5 GM / aztreonam 1.5 GM InjectionSYbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5
2705355avibactam sodium / aztreonam 2 GM InjectionSYbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5
2705360Emblaveo (avibactam 500 MG / aztreonam 1500 MG ) InjectionSYbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5
2705360Emblaveo 2 GM InjectionSYbe1a6c99-d4b3-46d7-9e99-6e5f9fab556a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0074-3878-010007438780112 mL in 1 VIAL, SINGLE-DOSE12 mlHistorical
0074-3878-100007438781010 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01) 2025-02-07NoNoHistorical