Prescription drug · ANDA
Penicillin G Potassium NDC 83634-102
Penicillin g potassium 5000000 [iU]/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Avenacy Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-102-20 | 83634010220 | 10 VIAL in 1 CARTON (83634-102-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (83634-102-41)Marketed from Feb 1, 2025 |
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 G Potassium
- Generic name (nonproprietary)
- penicillin g potassium
- Active ingredients
- Penicillin g potassium — 5000000 [iU]/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Avenacy Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065448
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 83634-102_727994cd-436d-4347-a023-5a861abd3264SPL ID 727994cd-436d-4347-a023-5a861abd3264SPL set ID 969a421e-37d8-499e-9e89-67e210bd5d9dRxCUI 863538UNII VL775ZTH4C
- 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
N483634010220followed by a unit qualifier and the quantityPackage 83634-0102-20. 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 Therapy Penicillin G Potassium for Injection is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium for Injection may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued. CLINICA…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065448
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 G Potassium | Penicillin g potassium 20000000 [iU]/1 | Injection, Powder, For solutionIntravenous | Avenacy Inc. | 83634-103 |
| Penicillin G Potassium | Penicillin g potassium 20000000 [iU]/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-312 |
| Penicillin G Potassium | Penicillin g potassium 5000000 [iU]/1 | Injection, Powder, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-311 |
| Penicillin G Potassium | Penicillin g potassium 20000000 [iU]/1 | Injection, Powder, For solutionIntravenous | NorthStar Rx, LLC | 72603-345 |
| Penicillin G Potassium | Penicillin g potassium 20000000 [iU]/1 | Injection, Powder, For solutionIntravenous | Athenex Pharmaceutical Division, LLC. | 70860-127 |
| Penicillin G Potassium | Penicillin g potassium 5000000 [iU]/1 | Injection, Powder, For solutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1689 |
| Penicillin G Potassium | Penicillin g potassium 5000000 [iU]/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-153 |
| Penicillin G Potassium | Penicillin g potassium 20000000 [iU]/1 | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-154 |
| Penicillin G Potassium | Penicillin g potassium 5000000 [iU]/1 | Injection, Powder, For solutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1709 |
| Penicillin G Potassium | Penicillin g potassium 5000000 [iU]/1 | Injection, Powder, For solutionIntramuscular, Intravenous | NorthStar Rx, LLC | 72603-210 |