Prescription drug · ANDA
Pyridostigmine Bromide NDC 68084-494
Pyridostigmine bromide 60 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-494-01 | 68084049401 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-494-01) / 1 TABLET in 1 BLISTER PACK (68084-494-11)Marketed from Oct 4, 2011 |
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
- American Health PackagingNDC labeler code 68084
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040502
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 68084-494_386b22b2-6b00-f2c0-e063-6394a90a0d43SPL ID 386b22b2-6b00-f2c0-e063-6394a90a0d43SPL set ID 30cb0b9f-e308-4501-90c2-b17349c048b7RxCUI 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
N468084049401followed by a unit qualifier and the quantityPackage 68084-0494-01. 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 68084-494
- What is NDC 68084-494?
- 68084-494 is the product NDC for Pyridostigmine Bromide, Pyridostigmine bromide 60 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, 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?
- American Health Packaging, NDC labeler code 68084. 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?
- 18 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 | Method Pharmaceuticals, LLC | 58657-811 | 58657-0811-0158657-0811-3058657-0811-90 |
| 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 |
Other NDCs under ANDA 040502
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 | Amneal Pharmaceuticals of New York LLC | 0115-2134 |
| Pyridostigmine Bromide | Pyridostigmine bromide 60 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 0115-3511 |