Prescription drug · NDA
Emblaveo (Aztreonam and avibactam) NDC 0074-3878
Aztreonam 127 mg/mL; Avibactam 42.3 mg/mL · Powder, For solution · Intravenous · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-3878-10 | 0007438781000074387810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)Marketed from Feb 7, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Emblaveo
- Generic name (nonproprietary)
- aztreonam and avibactam
- Dosage form
- Powder, For solution
- Route
- Intravenous
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217906
- Marketing start
- Listing expires
- Other FDA classes
- Monobactams (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 0074-3878_35d361ac-c141-4544-bb6a-a6c308d64497SPL ID 35d361ac-c141-4544-bb6a-a6c308d64497SPL set ID be1a6c99-d4b3-46d7-9e99-6e5f9fab556aRxCUI 2705355, 2705360UNII G2B4VE5GH8, 7352665165
- Pharmacologic class
- Monobactam Antibacterial; beta Lactamase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400074387810followed by a unit qualifier and the quantityPackage 00074-3878-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens . Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacter…
Excerpt only. Read the full label for complete information.
About NDC 0074-3878
- What is NDC 0074-3878?
- 0074-3878 is the product NDC for Emblaveo, Aztreonam 127 mg/mL; Avibactam 42.3 mg/mL powder, for solution, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Emblaveo (Aztreonam and avibactam).
- What is the active ingredient?
- Aztreonam, Avibactam.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Emblaveo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.