Prescription drug · NDA
Pyridostigmine bromide NDC 60846-559
Pyridostigmine bromide 105 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60846-559-10 | 60846055910 | 10 CARTON in 1 BAG (60846-559-10) / 1 BLISTER PACK in 1 CARTON (60846-559-27) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 9, 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 — 105 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 60846
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217604
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 60846-559_d6813c89-ca7b-4495-86ac-137a38854371SPL ID d6813c89-ca7b-4495-86ac-137a38854371SPL set ID 52d6f195-165a-400b-a13b-489e94bcf0b0RxCUI 2695047UNII KVI301NA53UPC 0360846559279, 0360846559101
- 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
N460846055910followed by a unit qualifier and the quantityPackage 60846-0559-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Pyridostigmine bromide is indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults. Pyridostigmine bromide is intended for use in conjunction with protective garments, including a mask. At the first sign of nerve agent poisoning, pyridostigmine bromide should be stopped, and atropine and pralidoxime therapy started immediately. The evidence for the effectiveness of pyridostigmine bromide as pretreatment against soman-induced toxicity was derived from animal studies alone [see Clinical Studies (14) ]. FOR MILITARY MEDICAL USE ONLY Pyridostigmine bromide is a cholinesterase inhibitor indicated for pretreatment against the lethal effects of soman nerve agen…
Excerpt only. Read the full label for complete information.
About NDC 60846-559
- What is NDC 60846-559?
- 60846-559 is the product NDC for Pyridostigmine bromide, Pyridostigmine bromide 105 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. 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?
- Amneal Pharmaceuticals LLC, NDC labeler code 60846. 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 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 |
| pyridostigmine bromide | Pyridostigmine bromide 60 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6622 | 00904-6622-5900904-6622-61 |