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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217906-001EMBLAVEOAVIBACTAM SODIUM; AZTREONAMEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07
N217906-00176120872026-11-12Drug product2025-03-07
N217906-00188354552030-10-08Drug product2025-03-07
N217906-00184710252031-08-12Drug substance2025-03-07
N217906-00189695662032-06-15Drug substance2025-03-07
N217906-00192843142032-06-15Drug substance2025-03-07
N217906-00196951222032-06-15Drug substance, Drug product2025-03-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217906-001NP2028-02-07
N217906-001GAIN2033-02-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-001EMBLAVEOEQ 0.5GM BASE/VIAL;1.5GM/VIALPOWDER / INTRAVENOUSRLD, RS2025-02-07a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00176120872026-11-12Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00188354552030-10-08Drug product2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00184710252031-08-12Drug substance2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00189695662032-06-15Drug substance2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00192843142032-06-15Drug substance2025-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-00196951222032-06-15Drug substance, Drug product2025-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00176120872026-11-12Drug product2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00188354552030-10-08Drug product2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00184710252031-08-12Drug substance2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00189695662032-06-15Drug substance2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00192843142032-06-15Drug substance2025-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-00196951222032-06-15Drug substance, Drug product2025-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00176120872026-11-12Drug product2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00188354552030-10-08Drug product2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00184710252031-08-12Drug substance2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00189695662032-06-15Drug substance2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00192843142032-06-15Drug substance2025-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-00196951222032-06-15Drug substance, Drug product2025-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00176120872026-11-12Drug product2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00188354552030-10-08Drug product2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00184710252031-08-12Drug substance2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00189695662032-06-15Drug substance2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00192843142032-06-15Drug substance2025-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217906-00196951222032-06-15Drug substance, Drug product2025-03-07fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00171125922026-01-07U-4147Drug substance, Drug product2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00176120872026-11-12Drug product2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00188354552030-10-08Drug product2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00184710252031-08-12Drug substance2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00189695662032-06-15Drug substance2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00192843142032-06-15Drug substance2025-03-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-00196951222032-06-15Drug substance, Drug product2025-03-07a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N217906-001NP2028-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217906-001GAIN2033-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-001NP2028-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217906-001GAIN2033-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217906-001NP2028-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217906-001GAIN2033-02-076a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-001NP2028-02-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217906-001GAIN2033-02-07a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G2B4VE5GH8Internal UNII lookup
7352665165Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be1a6c99-d4b3-46d7-9e99-6e5f9fab556aAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMBLAVEOAZTREONAM AND AVIBACTAMAbbVie Inc.be1a6c99-d4b3-46d7-9e99-6e5f9fab556a2026-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 217906
application number: NDA217906
ndc (product): 0074-3878

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) 2025-02-07NoNoCurrent