emblaveo

Generic: aztreonam and avibactam

Labeler: abbvie inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name emblaveo
Generic Name aztreonam and avibactam
Labeler abbvie inc.
Dosage Form POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

avibactam 42.3 mg/mL, aztreonam 127 mg/mL

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-3878
Product ID 0074-3878_2f93ac82-b7b6-4237-93b3-9a2f970d25ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217906
Listing Expiration 2026-12-31
Marketing Start 2025-02-07

Pharmacologic Class

Established (EPC)
beta lactamase inhibitor [epc] monobactam antibacterial [epc]
Mechanism of Action
beta lactamase inhibitors [moa]
Chemical Structure
monobactams [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00743878
Hyphenated Format 0074-3878

Supplemental Identifiers

RxCUI
2705355 2705360
UNII
7352665165 G2B4VE5GH8
NUI
N0000175930 N0000000202 N0000175493 M0014030

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name emblaveo (source: ndc)
Generic Name aztreonam and avibactam (source: ndc)
Application Number NDA217906 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 42.3 mg/mL
  • 127 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)
source: ndc

Packages (1)

0074-3878-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)

Ingredients (2)

avibactam (42.3 mg/mL) aztreonam (127 mg/mL)

Linked Drug Pages (1)

EMBLAVEO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2f93ac82-b7b6-4237-93b3-9a2f970d25ac", "openfda": {"nui": ["N0000175930", "N0000000202", "N0000175493", "M0014030"], "unii": ["7352665165", "G2B4VE5GH8"], "rxcui": ["2705355", "2705360"], "spl_set_id": ["be1a6c99-d4b3-46d7-9e99-6e5f9fab556a"], "pharm_class_cs": ["Monobactams [CS]"], "pharm_class_epc": ["beta Lactamase Inhibitor [EPC]", "Monobactam Antibacterial [EPC]"], "pharm_class_moa": ["beta Lactamase Inhibitors [MoA]"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10)  / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)", "package_ndc": "0074-3878-10", "marketing_start_date": "20250207"}], "brand_name": "EMBLAVEO", "product_id": "0074-3878_2f93ac82-b7b6-4237-93b3-9a2f970d25ac", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Monobactam Antibacterial [EPC]", "Monobactams [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0074-3878", "generic_name": "aztreonam and avibactam", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EMBLAVEO", "active_ingredients": [{"name": "AVIBACTAM", "strength": "42.3 mg/mL"}, {"name": "AZTREONAM", "strength": "127 mg/mL"}], "application_number": "NDA217906", "marketing_category": "NDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}