What is NDC 0781-3040?

0781-3040 is the product NDC for Regonol (pyridostigmine bromide), Pyridostigmine bromide 5 mg/mL injection, solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Regonol?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Regonol NDC 0781-3040 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-3040Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-3040Add 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
0781-3040-95	00781304095	10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72)Marketed from May 10, 2005

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): Regonol
Generic name (nonproprietary): pyridostigmine bromide
Active ingredients: Pyridostigmine bromide — 5 mg/mL
Dosage form: Injection, Solution
Route: Intravenous, Parenteral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 017398
Marketing start: May 10, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 0781-3040_f1bb6a46-3153-4406-98da-98bb3113d46dSPL ID f1bb6a46-3153-4406-98da-98bb3113d46dSPL set ID 208af931-a44e-43bf-a265-8e08534dc55fRxCUI 903851, 903855UNII KVI301NA53
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

N400781304095 followed by a unit qualifier and the quantity

Package 00781-3040-95. 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 Apr 1, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE REGONOL ® (pyridostigmine bromide injection, USP) is indicated as a reversal agent or antagonist to the neuromuscular blocking effects of nondepolarizing muscle relaxants.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3040

What is NDC 0781-3040?: 0781-3040 is the product NDC for Regonol (pyridostigmine bromide), Pyridostigmine bromide 5 mg/mL injection, solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Regonol (Pyridostigmine Bromide).
What is the active ingredient?: Pyridostigmine bromide.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Regonol?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Regonol (Pyridostigmine bromide) NDC 0781-3040