Prescription drug · ANDA
Ampicillin NDC 0781-2145
Ampicillin trihydrate 500 mg/1 · Capsule · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-2145-01 | 0078121450100781214501 | 100 CAPSULE in 1 BOTTLE (0781-2145-01)Marketed from Aug 29, 1995 | |
| 0781-2145-05 | 0078121450500781214505 | 500 CAPSULE in 1 BOTTLE (0781-2145-05)Marketed from Aug 29, 1995 |
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)
- Ampicillin
- Generic name (nonproprietary)
- ampicillin
- Active ingredients
- Ampicillin trihydrate — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064082
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 0781-2145_0202d39a-7586-4abd-9b9f-ac935aadccf2SPL ID 0202d39a-7586-4abd-9b9f-ac935aadccf2SPL set ID 0a66c5c3-63bf-46e3-835e-26b555ab6954RxCUI 308212, 313800UNII HXQ6A1N7R6UPC 0307812145050, 0307812145012
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400781214501followed by a unit qualifier and the quantityPackage 00781-2145-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules, ampicillin for oral suspension and other antibacterial drugs, ampicillin capsules and ampicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy. Ampicillin capsules and ampicillin for oral suspension are indicated in the trea…
Excerpt only. Read the full label for complete information.
About NDC 0781-2145
- What is NDC 0781-2145?
- 0781-2145 is the product NDC for Ampicillin, Ampicillin trihydrate 500 mg/1 capsule, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ampicillin.
- What is the active ingredient?
- Ampicillin trihydrate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. 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?
- 68 other product NDCs are listed under this name. See all Ampicillin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ampicillin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ampicillinampicillin sodium | Ampicillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9760 | 00404-9760-99 |
| Ampicillin | Ampicillin sodium 500 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-312 | 83270-0312-10 |
| Ampicillin | Ampicillin sodium 250 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-311 | 83270-0311-10 |
| Ampicillin | Ampicillin sodium 1 g/1 | Injection, Powder, For solutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-313 | 83270-0313-10 |
| Ampicillin | Ampicillin sodium 2 g/1 | Injection, Powder, For solutionIntravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-314 | 83270-0314-10 |
| Ampicillin | Ampicillin sodium 10 g/1 | Injection, Powder, For solutionIntravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-315 | 83270-0315-01 |
| Ampicillin | Ampicillin sodium 10 g/1 | Injection, Powder, For solutionIntravenous | Armas Pharmaceuticals Inc. | 72485-423 | 72485-0423-10 |
| Ampicillinampicillin sodium | Ampicillin sodium 10 g/100mL | Injection, Powder, For solutionIntravenous | Avenacy Inc. | 83634-100 | 83634-0100-99 |
| Ampicillinampicillin injection | Ampicillin sodium 500 mg/500mg | Powder, For solutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-915 | 23155-0915-41 |
| Ampicillinampicillin injection | Ampicillin sodium 250 mg/250mg | Powder, For solutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-914 | 23155-0914-41 |
Other NDCs under ANDA 064082
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 | Ampicillin trihydrate 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2607 |