What is NDC 0115-2134?

0115-2134 is the product NDC for Pyridostigmine Bromide, Pyridostigmine bromide 30 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pyridostigmine Bromide?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pyridostigmine Bromide NDC 0115-2134 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-2134Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-2134Add 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
0115-2134-01	00115213401	21 TABLET in 1 BOTTLE (0115-2134-01)Marketed from Aug 8, 2022

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): Pyridostigmine Bromide
Generic name (nonproprietary): pyridostigmine bromide
Active ingredients: Pyridostigmine bromide — 30 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040502
Marketing start: Aug 8, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 0115-2134_83d6b85c-0cd0-467c-90aa-6998f5302559SPL ID 83d6b85c-0cd0-467c-90aa-6998f5302559SPL set ID 91ca7bcf-d2cc-4cb3-bfbe-c294fd707524RxCUI 903841UNII KVI301NA53UPC 0301152134019
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400115213401 followed by a unit qualifier and the quantity

Package 00115-2134-01. 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 Dec 31, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-2134

What is NDC 0115-2134?: 0115-2134 is the product NDC for Pyridostigmine Bromide, Pyridostigmine bromide 30 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pyridostigmine Bromide.
What is the active ingredient?: Pyridostigmine bromide.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pyridostigmine Bromide?: 17 other product NDCs are listed under this name. See all Pyridostigmine Bromide 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 Pyridostigmine Bromide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pyridostigmine bromide	Pyridostigmine bromide 105 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	60846-559	60846-0559-10
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-811	58657-0811-0158657-0811-3058657-0811-90
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-470	62559-0470-01
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/5mL	SolutionOral	Acella Pharmaceuticals, LLC	42192-626	42192-0626-16
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/5mL	SolutionOral	Novadoz Pharmaceuticals LLC	72205-098	72205-0098-72
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/5mL	SolutionOral	Amneal Pharmaceuticals NY LLC	69238-1731	69238-1731-02
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/5mL	SolutionOral	VistaPharm, LLC	66689-406	66689-0406-10
Pyridostigmine Bromide	Pyridostigmine bromide 30 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-810	58657-0810-21
Pyridostigmine Bromide	Pyridostigmine bromide 180 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-220	64980-0220-03
pyridostigmine bromide	Pyridostigmine bromide 60 mg/1	TabletOral	Major Pharmaceuticals	0904-6622	00904-6622-5900904-6622-61

All 18 Pyridostigmine Bromide NDCs

Other NDCs under ANDA 040502

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

FDA NDC Directory listings under ANDA 040502
Product	Strength	Form · route	Labeler	Product NDC
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-3511
Pyridostigmine Bromide	Pyridostigmine bromide 60 mg/1	TabletOral	American Health Packaging	68084-494