Prescription drug · ANDA
Pyridostigmine (Pyridostigmine bromide oral) NDC 70954-148
Pyridostigmine bromide 60 mg/5mL · Solution · Oral · Novitium Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-148-10 | 70954014810 | 473 mL in 1 BOTTLE (70954-148-10)Marketed from Mar 11, 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
- Generic name (nonproprietary)
- pyridostigmine bromide oral
- Active ingredients
- Pyridostigmine bromide — 60 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Novitium Pharma LLCNDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211694
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-148_ef78ff05-8e0f-463a-88cd-ca9a01aed76aSPL ID ef78ff05-8e0f-463a-88cd-ca9a01aed76aSPL set ID ef78ff05-8e0f-463a-88cd-ca9a01aed76aRxCUI 903843UNII 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
N470954014810followed by a unit qualifier and the quantityPackage 70954-0148-10. 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 & USAGE Pyridostigmine Bromide Oral Solution, USP is useful in the treatment of myasthenia gravis.
Excerpt only. Read the full label for complete information.
About NDC 70954-148
- What is NDC 70954-148?
- 70954-148 is the product NDC for Pyridostigmine (pyridostigmine bromide oral), Pyridostigmine bromide 60 mg/5mL solution, listed with the FDA by Novitium Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pyridostigmine (Pyridostigmine bromide oral).
- What is the active ingredient?
- Pyridostigmine bromide.
- Who is the labeler?
- Novitium Pharma LLC, NDC labeler code 70954. 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?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 211694
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/5mL | SolutionOral | VistaPharm, LLC | 66689-406 |