Prescription drug · ANDA
Pyridostigmine Bromide NDC 58657-810
Pyridostigmine bromide 30 mg/1 · Tablet · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-810-21 | 58657081021 | 21 TABLET in 1 BOTTLE (58657-810-21)Marketed from Jun 1, 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)
- Pyridostigmine Bromide
- Generic name (nonproprietary)
- pyridostigmine bromide
- Active ingredients
- Pyridostigmine bromide — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211181
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 58657-810_41b66d64-08b1-bd0c-e063-6394a90a5b86SPL ID 41b66d64-08b1-bd0c-e063-6394a90a5b86SPL set ID e756717f-941b-42f2-ba3b-03798c005ae7RxCUI 903841UNII KVI301NA53
- Pharmacologic class
- Cholinesterase Inhibitor
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
N458657081021followed by a unit qualifier and the quantityPackage 58657-0810-21. 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 Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211181
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 |
|---|---|---|---|---|
| Pyridostigmine Bromide | Pyridostigmine bromide 60 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-811 |