Prescription drug · ANDA
Penicillin V Potassium NDC 43063-704
Penicillin v potassium 250 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-704-06 | 43063070406 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-06)Marketed from Nov 2, 2016 | |
| 43063-704-20 | 43063070420 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-20)Marketed from Sep 19, 2016 | |
| 43063-704-28 | 43063070428 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-28)Marketed from Aug 22, 2016 | |
| 43063-704-40 | 43063070440 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-704-40)Marketed from Dec 15, 2016 |
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/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065435
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 43063-704_4147bed7-05e0-1bc4-e063-6294a90a04d8SPL ID 4147bed7-05e0-1bc4-e063-6294a90a04d8SPL set ID 9bc7006d-a482-47c4-a138-5380ce927812RxCUI 834061UNII 146T0TU1JBUPC 0343063704288
- 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
N443063070406followed by a unit qualifier and the quantityPackage 43063-0704-06. 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 penicillin V potassium and other antibacterial drugs, penicillin V potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sen…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065435
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 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-175 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-176 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5081 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-676 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3640 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3176 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4652 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4651 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3299 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4697 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9110 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-756 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3425 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4753 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5543 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-235 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-234 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3506 |
| Penicillin V Potassium | Penicillin v potassium 250 mg/1 | Tablet, Film coatedOral | Rising Health, LLC | 57237-040 |
| Penicillin V Potassium | Penicillin v potassium 500 mg/1 | Tablet, Film coatedOral | Rising Health, LLC | 57237-041 |
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