Prescription drug · ANDA
Neostigmine Methylsulfate NDC 0641-6264
Neostigmine methylsulfate .5 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6264-10 | 00641626410 | 10 VIAL, MULTI-DOSE in 1 CARTON (0641-6264-10) / 10 mL in 1 VIAL, MULTI-DOSE (0641-6264-01)Marketed from Dec 28, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207042
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 0641-6264_2ddab018-16a5-455c-9f43-8e16533ae808SPL ID 2ddab018-16a5-455c-9f43-8e16533ae808SPL set ID 28365ed5-8332-48ac-a93d-b165ac3c6eacRxCUI 311935, 311936UNII 98IMH7M386
- 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
N400641626410followed by a unit qualifier and the quantityPackage 00641-6264-10. 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)
1. INDICATIONS AND USAGE Neostigmine Methylsulfate Injection, USP is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Neostigmine Methylsulfate Injection, USP, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207042
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 | InjectionIntravenous | Civica, Inc. | 72572-462 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6277 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6149 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate .5 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6150 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6265 |