Prescription drug · ANDA
Ampicillin NDC 44567-104
Ampicillin sodium 10 g/1 · Injection, Powder, For solution · Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-104-01 | 44567010401 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-104-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Jul 3, 2019 |
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
- Generic name (nonproprietary)
- ampicillin
- Active ingredients
- Ampicillin sodium — 10 g/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- WG Critical Care, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201404
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 44567-104_0e3ba13c-dfd5-4c47-9c8f-f621d4e93c44SPL ID 0e3ba13c-dfd5-4c47-9c8f-f621d4e93c44SPL set ID 12b6ac82-ca74-4f88-99ea-ae4a1c419b70RxCUI 789980UNII JFN36L5S8KUPC 0344567104017
- Pharmacologic class
- Penicillin-class 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
N444567010401followed by a unit qualifier and the quantityPackage 44567-0104-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing), H. influenzae and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria ( Listeria monocytogenes, N. meningitidis ). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201404
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 |
|---|---|---|---|---|
| Ampicillinampicillin sodium | Ampicillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | Athenex Pharmaceutical Division, LLC. | 70860-118 |
| Ampicillinampicillin sodium | Ampicillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | NorthStar Rx, LLC | 72603-578 |
| Ampicillin Sodium | Ampicillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-197 |
| Ampicillinampicillin sodium | Ampicillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | Avenacy Inc. | 83634-100 |