Prescription drug · NDA
Neostigmine Methylsulfate NDC 65219-811
Neostigmine methylsulfate 1 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-811-10 | 65219081110 | 10 VIAL, MULTI-DOSE in 1 TRAY (65219-811-10) / 10 mL in 1 VIAL, MULTI-DOSE (65219-811-01)Marketed from Jan 9, 2023 |
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)
- Neostigmine Methylsulfate
- Generic name (nonproprietary)
- neostigmine methylsulfate
- Active ingredients
- Neostigmine methylsulfate — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203629
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 65219-811_0831f9a8-b6ff-4b49-91ad-8177f968f543SPL ID 0831f9a8-b6ff-4b49-91ad-8177f968f543SPL set ID 088f96eb-20b8-48f8-ac83-329f75a44ce1RxCUI 311936UNII 98IMH7M386UPC 0365219811015
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465219081110followed by a unit qualifier and the quantityPackage 65219-0811-10. 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)
Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery. Neostigmine Methylsulfate, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203629
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 |
|---|---|---|---|---|
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 76045-214 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-415 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate .5 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-413 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate .5 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-413 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 76045-383 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-415 |