What is NDC 0548-9601?

0548-9601 is the product NDC for Neostigmine Methylsulfate, Neostigmine methylsulfate .5 mg/mL injection, listed with the FDA by Amphastar Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Neostigmine Methylsulfate NDC 0548-9601

NDC codes

FDA NDC Directory

Product NDC (as listed)0548-9601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00548-9601Add 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
0548-9601-00	0054896010000548960100	10 CARTON in 1 PACKAGE (0548-9601-00) / 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 25, 2017

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
Labeler: Amphastar Pharmaceuticals, Inc.NDC labeler code 0548
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209933
Marketing start: Sep 25, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 0548-9601_32069cca-ad21-4afc-9c23-5ab376b0237aSPL ID 32069cca-ad21-4afc-9c23-5ab376b0237aSPL set ID e47a4a4c-0e7c-40b6-9950-5b3adadcac22RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N400548960100 followed by a unit qualifier and the quantity

Package 00548-9601-00. 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 Jun 1, 2023.

Indications (excerpt from the label)

Neostigmine Methylsulfate Injection, USP, is a cholinesterase inhibitor indicated for the reversal of the effects of nondepolarizing 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.

Full label on DailyMed (opens in a new tab)

About NDC 0548-9601

What is NDC 0548-9601?: 0548-9601 is the product NDC for Neostigmine Methylsulfate, Neostigmine methylsulfate .5 mg/mL injection, listed with the FDA by Amphastar Pharmaceuticals, Inc.. 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?: Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. 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.

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 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 .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 48 Neostigmine Methylsulfate NDCs

Other NDCs under ANDA 209933

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

FDA NDC Directory listings under ANDA 209933
Product	Strength	Form · route	Labeler	Product NDC
Neostigmine Methylsulfate	Neostigmine methylsulfate 1 mg/mL	InjectionIntravenous	Amphastar Pharmaceuticals, Inc.	0548-9602
Neostigmine Methylsulfate	Neostigmine methylsulfate 1 mg/mL	InjectionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1557
Neostigmine Methylsulfate	Neostigmine methylsulfate 1 mg/mL	InjectionIntravenous	Medical Purchasing Solutions, LLC	71872-7143