Prescription drug · ANDA
Ampicillin Sodium and Sulbactam Sodium (Ampicillin sodium, sulbactam sodium) NDC 72485-416
Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-416-10 | 7248504161072485041610 | 10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01)Marketed from Jul 21, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Ampicillin Sodium and Sulbactam Sodium
- Generic name (nonproprietary)
- ampicillin sodium, sulbactam sodium
- Active ingredients
- Ampicillin sodium — 1 g/1Sulbactam sodium — .5 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Armas Pharmaceuticals Inc.NDC labeler code 72485
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201024
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 72485-416_44a1fdb7-5659-23bc-e063-6294a90a1ccdSPL ID 44a1fdb7-5659-23bc-e063-6294a90a1ccdSPL set ID ac6f8158-9d7e-4b99-af3c-0407c5287b57RxCUI 1659592, 1659598UNII JFN36L5S8K, DKQ4T82YE6UPC 0372485416011, 0372485417018
- 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
N472485041610followed by a unit qualifier and the quantityPackage 72485-0416-10. 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)
INDICATIONS AND USAGE Ampicillin and sulbactam for injection 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 ,* 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 strains of Escherichia coli , Klebsiella spp. (includi…
Excerpt only. Read the full label for complete information.
About NDC 72485-416
- What is NDC 72485-416?
- 72485-416 is the product NDC for Ampicillin Sodium and Sulbactam Sodium, Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 injection, powder, for solution, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ampicillin Sodium and Sulbactam Sodium (Ampicillin sodium, sulbactam sodium).
- What is the active ingredient?
- Ampicillin sodium, Sulbactam sodium.
- Who is the labeler?
- Armas Pharmaceuticals Inc., NDC labeler code 72485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ampicillin Sodium and Sulbactam Sodium?
- 6 other product NDCs are listed under this name. See all Ampicillin Sodium and Sulbactam Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ampicillin Sodium and Sulbactam Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Civica, Inc. | 72572-136 | 72572-0136-10 |
| Ampicillin Sodium and Sulbactam Sodiumampicillin sodium, sulbactam sodium | Ampicillin sodium 10 g/15g; Sulbactam sodium 5 g/15g | Injection, Powder, For solutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-418 | 72485-0418-15 |
| Ampicillin Sodium and Sulbactam Sodiumampicillin sodium, sulbactam sodium | Ampicillin sodium 10 g/15g; Sulbactam sodium 5 g/15g | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-308 | 83270-0308-01 |
| Ampicillin Sodium and Sulbactam Sodiumampicillin sodium, sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-417 | 72485-0417-10 |
| ampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-304 | 83270-0304-10 |
| ampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-305 | 83270-0305-10 |
Other NDCs under ANDA 201024
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 |
|---|---|---|---|---|
| Ampicillin Sodium and Sulbactam Sodiumampicillin sodium, sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-417 |
| ampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Civica, Inc. | 72572-136 |
| ampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-304 |
| ampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-305 |