Prescription drug · ANDA
Ampicillin and Sulbactam (Ampicillin sodium and sulbactam sodium) NDC 71288-033
Ampicillin sodium 10 g/1; Sulbactam sodium 5 g/1 · Injection, Powder, For solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-033-75 | 7128800337571288003375 | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLEMarketed from Nov 27, 2006 |
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 and Sulbactam
- Generic name (nonproprietary)
- ampicillin sodium and sulbactam sodium
- Active ingredients
- Ampicillin sodium — 10 g/1Sulbactam sodium — 5 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065403
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 71288-033_92c74f7e-57ea-4eab-acd8-0798529a6db0SPL ID 92c74f7e-57ea-4eab-acd8-0798529a6db0SPL set ID 139b4b2e-46f7-44a8-9cc1-774afa463b80RxCUI 240984UNII 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
N471288003375followed by a unit qualifier and the quantityPackage 71288-0033-75. 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. (in…
Excerpt only. Read the full label for complete information.
About NDC 71288-033
- What is NDC 71288-033?
- 71288-033 is the product NDC for Ampicillin and Sulbactam, Ampicillin sodium 10 g/1; Sulbactam sodium 5 g/1 injection, powder, for solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ampicillin and Sulbactam (Ampicillin Sodium and Sulbactam Sodium).
- What is the active ingredient?
- Ampicillin sodium, Sulbactam sodium.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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 and Sulbactam?
- 26 other product NDCs are listed under this name. See all Ampicillin and Sulbactam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ampicillin and Sulbactam 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 and Sulbactam | Ampicillin sodium 10 g/1; Sulbactam sodium 5 g/1 | Injection, Powder, For solutionIntravenous | Avenacy, LLC | 83634-108 | 83634-0108-99 |
| Ampicillin and Sulbactam | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Avenacy, LLC | 83634-109 | 83634-0109-20 |
| Ampicillin and Sulbactam | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Avenacy, LLC | 83634-110 | 83634-0110-20 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-220 | 72603-0220-0172603-0220-10 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-335 | 72603-0335-0172603-0335-10 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 10 g/1; Sulbactam sodium 5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-444 | 72603-0444-01 |
| Ampicillin and Sulbactam | Sulbactam sodium 1 g/1; Ampicillin sodium 2 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-150 | 44567-0150-10 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntravenous | Eugia US LLC | 55150-178 | 55150-0178-99 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 2 g/1; Sulbactam sodium 1 g/1 | Injection, Powder, For solutionIntravenous | Eugia US LLC | 55150-179 | 55150-0179-99 |
| Ampicillin and Sulbactamampicillin sodium and sulbactam sodium | Ampicillin sodium 1 g/1; Sulbactam sodium .5 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Eugia US LLC | 55150-116 | 55150-0116-10 |
Other NDCs under ANDA 065403
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 and Sulbactam | Ampicillin sodium 100 mg/mL; Sulbactam sodium 50 mg/mL | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6118 |
| ampicillin and sulbactam | Ampicillin sodium 100 mg/mL; Sulbactam sodium 50 mg/mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-144 |