Prescription drug · ANDA
Penicillin V Potassium NDC 63187-533
Penicillin v potassium 250 mg/5mL · Powder, For solution · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-533-00 | 63187053300 | 100 mL in 1 BOTTLE (63187-533-00)Marketed from Aug 1, 2016 | |
| 63187-533-20 | 63187053320 | 200 mL in 1 BOTTLE (63187-533-20)Marketed from Sep 30, 1990 |
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)
- Penicillin V Potassium
- Generic name (nonproprietary)
- penicillin v potassium
- Active ingredients
- Penicillin v potassium — 250 mg/5mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 060456
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 63187-533_d9fdfb61-581b-4082-ac22-60dc2970ffa2SPL ID d9fdfb61-581b-4082-ac22-60dc2970ffa2SPL set ID 316aa904-09f1-4a8e-9adf-93cfc14f9a0aRxCUI 834040UNII 146T0TU1JB
- 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
N463187053300followed by a unit qualifier and the quantityPackage 63187-0533-00. 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 Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal infections (without bacteremia). Mild-to-moderate infections of the upper respira…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 060456
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 |
|---|---|---|---|---|
| Penicillin V Potassium | Penicillin v potassium 125 mg/5mL | Powder, For solutionOral | Chartwell RX, LLC | 62135-102 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/5mL | Powder, For solutionOral | Chartwell RX, LLC | 62135-103 |
| Penicillin V Potassium | Penicillin v potassium 125 mg/5mL | Powder, For solutionOral | Teva Pharmaceuticals USA, Inc. | 0093-4125 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/5mL | Powder, For solutionOral | Teva Pharmaceuticals USA, Inc. | 0093-4127 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/5mL | Powder, For solutionOral | Preferred Pharmaceuticals, Inc | 68788-9852 |
| Penicillin V Potassium | Penicillin v potassium 125 mg/5mL | Powder, For solutionOral | Preferred Pharmaceuticals, Inc | 68788-9853 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/5mL | Powder, For solutionOral | A-S Medication Solutions | 50090-0409 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/5mL | Powder, For solutionOral | NuCare Pharmaceuticals,Inc. | 68071-1820 |