Prescription drug · ANDA
Neostigmine methylsulfate NDC 68083-384
Neostigmine methylsulfate 1 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-384-10 | 6808303841068083038410 | 10 CARTON in 1 CARTON (68083-384-10) / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-384-01) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 21, 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)
- Neostigmine methylsulfate
- Generic name (nonproprietary)
- neostigmine methylsulfate
- Active ingredients
- Neostigmine methylsulfate — 1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212968
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 68083-384_d9a28c8e-2f5b-48a5-9852-8b5a73fe8d58SPL ID d9a28c8e-2f5b-48a5-9852-8b5a73fe8d58
- 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
N468083038410followed by a unit qualifier and the quantityPackage 68083-0384-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68083-384
- What is NDC 68083-384?
- 68083-384 is the product NDC for Neostigmine methylsulfate, Neostigmine methylsulfate 1 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neostigmine methylsulfate.
- What is the active ingredient?
- Neostigmine methylsulfate.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Neostigmine methylsulfate?
- 45 other product NDCs are listed under this name. See all Neostigmine methylsulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Neostigmine methylsulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Neostigmine Methylsulfate | Neostigmine methylsulfate .5 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-348 | 55150-0348-10 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Eugia US LLC | 55150-349 | 55150-0349-10 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate .5 mg/mL | InjectionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-517 | 23155-0517-41 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-518 | 23155-0518-41 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | Injection, SolutionIntravenous | Dr.Reddys Laboratories Inc | 43598-945 | 43598-0945-58 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate .5 mg/mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-805 | 70069-0805-10 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-806 | 70069-0806-10 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7271 | 71872-7271-01 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate .5 mg/mL | InjectionIntravenous | Indoco Remedies Limited | 14445-413 | 14445-0413-01 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Indoco Remedies Limited | 14445-414 | 14445-0414-01 |
Other NDCs under ANDA 212968
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 .5 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-383 |
| Neostigmine methylsulfate | Neostigmine methylsulfate .5 mg/mL | InjectionIntravenous | Xiromed LLC | 70700-171 |
| Neostigmine methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | Xiromed LLC | 70700-172 |
| Neostigmine methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | ProPharma Distribution | 84549-172 |