Prescription drug · ANDA
Pyridostigmine Bromide NDC 58657-811
Pyridostigmine bromide 60 mg/1 · Tablet · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-811-01 | 58657081101 | 100 TABLET in 1 BOTTLE (58657-811-01)Marketed from Jun 15, 2024 | |
| 58657-811-30 | 58657081130 | 30 TABLET in 1 BOTTLE (58657-811-30)Marketed from Jun 15, 2024 | |
| 58657-811-90 | 58657081190 | 90 TABLET in 1 BOTTLE (58657-811-90)Marketed from Jun 15, 2024 |
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 — 60 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLCNDC labeler code 58657
- 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 58657-811_4aa4cfc7-d427-5306-e063-6394a90a628dSPL ID 4aa4cfc7-d427-5306-e063-6394a90a628dSPL set ID 1aa7a886-c726-cc91-e063-6294a90a1af1RxCUI 903857UNII 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
N458657081101followed by a unit qualifier and the quantityPackage 58657-0811-01. 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 Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.
Excerpt only. Read the full label for complete information.
About NDC 58657-811
- What is NDC 58657-811?
- 58657-811 is the product NDC for Pyridostigmine Bromide, Pyridostigmine bromide 60 mg/1 tablet, listed with the FDA by Method Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pyridostigmine Bromide.
- What is the active ingredient?
- Pyridostigmine bromide.
- Who is the labeler?
- Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pyridostigmine Bromide?
- 17 other product NDCs are listed under this name. See all Pyridostigmine Bromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pyridostigmine Bromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pyridostigmine bromide | Pyridostigmine bromide 105 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 60846-559 | 60846-0559-10 |
| Pyridostigmine Bromide | Pyridostigmine bromide 60 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-470 | 62559-0470-01 |
| Pyridostigmine Bromide | Pyridostigmine bromide 60 mg/5mL | SolutionOral | Acella Pharmaceuticals, LLC | 42192-626 | 42192-0626-16 |
| Pyridostigmine Bromide | Pyridostigmine bromide 60 mg/5mL | SolutionOral | Novadoz Pharmaceuticals LLC | 72205-098 | 72205-0098-72 |
| Pyridostigmine Bromide | Pyridostigmine bromide 30 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-2134 | 00115-2134-01 |
| Pyridostigmine Bromide | Pyridostigmine bromide 60 mg/5mL | SolutionOral | Amneal Pharmaceuticals NY LLC | 69238-1731 | 69238-1731-02 |
| Pyridostigmine Bromide | Pyridostigmine bromide 60 mg/5mL | SolutionOral | VistaPharm, LLC | 66689-406 | 66689-0406-10 |
| Pyridostigmine Bromide | Pyridostigmine bromide 30 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-810 | 58657-0810-21 |
| Pyridostigmine Bromide | Pyridostigmine bromide 180 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-220 | 64980-0220-03 |
| pyridostigmine bromide | Pyridostigmine bromide 60 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6622 | 00904-6622-5900904-6622-61 |
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 30 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-810 |