Prescription drug · NDA
Unasyn (Ampicillin sodium and sulbactam sodium) NDC 0049-0014
Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Roerig
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0049-0014-83 | 0004900148300049001483 | 10 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)Marketed from Nov 22, 1991 |
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)
- Unasyn
- Generic name (nonproprietary)
- ampicillin sodium and sulbactam sodium
- Active ingredients
- Ampicillin sodium — 2 g/1Sulbactam sodium — 1 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- RoerigNDC labeler code 0049
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050608
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 0049-0014_04da40ca-b337-4cac-a8d7-8dc9d5301c23SPL ID 04da40ca-b337-4cac-a8d7-8dc9d5301c23SPL set ID 155c7ec0-5862-404f-b1d0-f278f8a8bbdaRxCUI 1659592, 1659595, 1659598, 1659600UNII JFN36L5S8K, DKQ4T82YE6
- Pharmacologic class
- Penicillin-class 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
N400049001483followed by a unit qualifier and the quantityPackage 00049-0014-83. 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 UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli , Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae ), Proteus mirabilis , Bacteroides fragilis , Enterobacter spp., and Acinetobacter calcoaceticus. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strain…
Excerpt only. Read the full label for complete information.
About NDC 0049-0014
- What is NDC 0049-0014?
- 0049-0014 is the product NDC for Unasyn, Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 injection, powder, for solution, listed with the FDA by Roerig. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Unasyn (Ampicillin sodium and sulbactam sodium).
- What is the active ingredient?
- Ampicillin sodium, Sulbactam sodium.
- Who is the labeler?
- Roerig, NDC labeler code 0049. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Unasyn?
- 2 other product NDCs are listed under this name. See all Unasyn NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Unasyn products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Unasynampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Roerig | 0049-0013 | 00049-0013-83 |
| Unasynampicillin sodium and sulbactam sodium | Ampicillin sodium 100 mg/mL; Sulbactam sodium 50 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | Roerig | 0049-0024 | 00049-0024-28 |
Other NDCs under NDA 050608
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 |
|---|---|---|---|---|
| Unasynampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Roerig | 0049-0013 |
| Unasynampicillin sodium and sulbactam sodium | Ampicillin sodium 100 mg/mL; Sulbactam sodium 50 mg/mL | Injection, Powder, For solutionIntramuscular, Intravenous | Roerig | 0049-0024 |