Prescription drug · ANDA
Neostigmine Methylsulfate NDC 14445-413
Neostigmine methylsulfate .5 mg/mL · Injection · Intravenous · Indoco Remedies Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14445-413-01 | 1444504130114445041301 | 10 CARTON in 1 PACKAGE (14445-413-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (14445-413-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Nov 26, 2021 |
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 — .5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Indoco Remedies LimitedNDC labeler code 14445
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210652
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 14445-413_23ba06a5-8314-49cf-b9de-fa3caad1a17aSPL ID 23ba06a5-8314-49cf-b9de-fa3caad1a17aSPL set ID 6657402f-1db2-411e-bf66-fca3902756c4RxCUI 311935, 311936UNII 98IMH7M386UPC 0314445414101, 0314445413104
- 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
N414445041301followed by a unit qualifier and the quantityPackage 14445-0413-01. 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 is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 14445-413
- What is NDC 14445-413?
- 14445-413 is the product NDC for Neostigmine Methylsulfate, Neostigmine methylsulfate .5 mg/mL injection, listed with the FDA by Indoco Remedies 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?
- Indoco Remedies Limited, NDC labeler code 14445. 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?
- 47 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 1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7271 | 71872-7271-01 |
| 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 | Indoco Remedies Limited | 14445-414 | 14445-0414-01 |
| Neostigmine Methylsulfate | Neostigmine methylsulfate 1 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1557 | 51662-1557-03 |
Other NDCs under ANDA 210652
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 | Indoco Remedies Limited | 14445-414 |