Prescription drug · ANDA
Pryidostigmine Bromide (Pyridostigmine bromide) NDC 16571-833
Pyridostigmine bromide 60 mg/5mL · Solution · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-833-16 | 1657108331616571083316 | 473 mL in 1 BOTTLE, PLASTIC (16571-833-16)Marketed from Sep 15, 2022 |
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)
- Pryidostigmine Bromide
- Generic name (nonproprietary)
- pyridostigmine bromide
- Active ingredients
- Pyridostigmine bromide — 60 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208797
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 16571-833_b46177b2-68dc-4958-a4ec-d4bd6d887456SPL ID b46177b2-68dc-4958-a4ec-d4bd6d887456SPL set ID beda905e-005a-439d-ac74-92db4e269780RxCUI 903843UNII KVI301NA53UPC 0316571833160
- 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
N416571083316followed by a unit qualifier and the quantityPackage 16571-0833-16. 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)
INDICATION Pyridostigmine bromide oral solution USP is useful in the treatment of myasthenia gravis.
Excerpt only. Read the full label for complete information.
About NDC 16571-833
- What is NDC 16571-833?
- 16571-833 is the product NDC for Pryidostigmine Bromide (pyridostigmine bromide), Pyridostigmine bromide 60 mg/5mL solution, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pryidostigmine Bromide (Pyridostigmine Bromide).
- What is the active ingredient?
- Pyridostigmine bromide.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pryidostigmine Bromide?
- 1 other product NDC are listed under this name. See all Pryidostigmine Bromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pryidostigmine 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) |
|---|---|---|---|---|---|
| Pryidostigmine Bromidepyridostigmine bromide | Pyridostigmine bromide 60 mg/5mL | SolutionOral | Apnar Pharma LP | 24689-104 | 24689-0104-01 |
Other NDCs under ANDA 208797
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 |
|---|---|---|---|---|
| Pryidostigmine Bromidepyridostigmine bromide | Pyridostigmine bromide 60 mg/5mL | SolutionOral | Apnar Pharma LP | 24689-104 |