NDC codes

FDA NDC Directory
Product NDC (as listed)71288-500Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71288-0500Add 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 NDC11-digit (billing)PackageCopy
71288-500-11712880500117128805001110 VIAL, MULTI-DOSE in 1 CARTON (71288-500-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-500-10)Marketed from Apr 5, 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 — .51 mg/mL
Dosage form
Injection
Route
Intravenous
Labeler
Meitheal Pharmaceuticals Inc.NDC labeler code 71288
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212804
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 71288-500_bf415978-8e01-4c77-e053-2995a90a9ea3SPL ID bf415978-8e01-4c77-e053-2995a90a9ea3SPL set ID 5a01a429-a346-4253-8994-b58d34b57974RxCUI 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

N471288050011 followed by a unit qualifier and the quantity

Package 71288-0500-11. 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.

Full label on DailyMed (opens in a new tab)

About NDC 71288-500

What is NDC 71288-500?
71288-500 is the product NDC for neostigmine methylsulfate, Neostigmine methylsulfate .51 mg/mL injection, listed with the FDA by Meitheal 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?
Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Neostigmine MethylsulfateNeostigmine methylsulfate .5 mg/mLInjectionIntravenousEugia US LLC55150-34855150-0348-10
Neostigmine MethylsulfateNeostigmine methylsulfate 1 mg/mLInjectionIntravenousEugia US LLC55150-34955150-0349-10
Neostigmine MethylsulfateNeostigmine methylsulfate .5 mg/mLInjectionIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-51723155-0517-41
Neostigmine MethylsulfateNeostigmine methylsulfate 1 mg/mLInjectionIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-51823155-0518-41
Neostigmine MethylsulfateNeostigmine methylsulfate 1 mg/mLInjection, SolutionIntravenousDr.Reddys Laboratories Inc43598-94543598-0945-58
Neostigmine MethylsulfateNeostigmine methylsulfate .5 mg/mLInjectionIntravenousSomerset Therapeutics, LLC70069-80570069-0805-10
Neostigmine MethylsulfateNeostigmine methylsulfate 1 mg/mLInjectionIntravenousSomerset Therapeutics, LLC70069-80670069-0806-10
Neostigmine MethylsulfateNeostigmine methylsulfate 1 mg/mLInjectionIntravenousMedical Purchasing Solutions, LLC71872-727171872-7271-01
Neostigmine MethylsulfateNeostigmine methylsulfate .5 mg/mLInjectionIntravenousIndoco Remedies Limited14445-41314445-0413-01
Neostigmine MethylsulfateNeostigmine methylsulfate 1 mg/mLInjectionIntravenousIndoco Remedies Limited14445-41414445-0414-01

All 46 neostigmine methylsulfate NDCs

Other NDCs under ANDA 212804

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

FDA NDC Directory listings under ANDA 212804
ProductStrengthForm · routeLabelerProduct NDC
neostigmine methylsulfateNeostigmine methylsulfate 1.02 mg/mLInjectionIntravenousMeitheal Pharmaceuticals Inc.71288-501

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