What is NDC 65219-811?

65219-811 is the product NDC for Neostigmine Methylsulfate, Neostigmine methylsulfate 1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 65219. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Neostigmine Methylsulfate NDC 65219-811

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-811Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0811Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65219-811-10	6521908111065219081110	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, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203629
Marketing start: Jan 8, 2015
Listing expires: Dec 31, 2027
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.

How CPT relates to drug billing

NDC on a medical claim

N465219081110 followed by a unit qualifier and the quantity

Package 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 Jan 22, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 65219-811

What is NDC 65219-811?: 65219-811 is the product NDC for Neostigmine Methylsulfate, Neostigmine methylsulfate 1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. 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?: Fresenius Kabi USA, LLC, NDC labeler code 65219. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Neostigmine Methylsulfate NDCs
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

All 46 Neostigmine Methylsulfate NDCs

Other NDCs under NDA 203629

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 203629
Product	Strength	Form · route	Labeler	Product NDC
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	63323-415
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	76045-383