Prescription drug · NDA
Azactam (Aztreonam) NDC 0003-2560
Aztreonam 1 g/1 · Injection, Powder, For solution · Intramuscular, Intravenous · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-2560-16 | 00003256016 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2560-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Apr 1, 2010 |
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)
- Azactam
- Generic name (nonproprietary)
- aztreonam
- Active ingredients
- Aztreonam — 1 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050580
- Marketing start
- Listing expires
- Other FDA classes
- Monobactams (Chemical structure)
- Identifiers
- Product ID 0003-2560_1308cf65-8900-4fc3-8a41-47b766adbd3aSPL ID 1308cf65-8900-4fc3-8a41-47b766adbd3aSPL set ID 9a105eaf-ee77-4016-beeb-d425a5565db2RxCUI 1664981, 1664984, 1664986, 1664988UNII G2B4VE5GH8
- Pharmacologic class
- Monobactam Antibacterial
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
N400003256016followed by a unit qualifier and the quantityPackage 00003-2560-16. 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)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. AZACTAM is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Urina…
Excerpt only. Read the full label for complete information.
About NDC 0003-2560
- What is NDC 0003-2560?
- 0003-2560 is the product NDC for Azactam (aztreonam), Aztreonam 1 g/1 injection, powder, for solution, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azactam (Aztreonam).
- What is the active ingredient?
- Aztreonam.
- Who is the labeler?
- E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Azactam?
- 2 other product NDCs are listed under this name. See all Azactam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azactam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azactamaztreonam | Aztreonam 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | E.R. Squibb & Sons, L.L.C. | 0003-2570 | 00003-2570-16 |
| Azactamaztreonam | Aztreonam 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | A-S Medication Solutions | 50090-7494 | 50090-7494-00 |
Other NDCs under NDA 050580
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Azactamaztreonam | Aztreonam 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | E.R. Squibb & Sons, L.L.C. | 0003-2570 |
| Azactamaztreonam | Aztreonam 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | A-S Medication Solutions | 50090-7494 |