NDC codes

FDA NDC Directory
Product NDC (as listed)0115-3511Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00115-3511Add 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
0115-3511-0100115351101100 TABLET in 1 BOTTLE (0115-3511-01)Marketed from Apr 24, 2003
0115-3511-0200115351102500 TABLET in 1 BOTTLE (0115-3511-02)Marketed from Apr 24, 2003

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 — 60 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
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 0115-3511_3d2e45fb-a83b-4e76-b1cd-9caf2b00a804SPL ID 3d2e45fb-a83b-4e76-b1cd-9caf2b00a804SPL set ID 0f56facf-1f0a-4ba5-876d-757b114dfa45RxCUI 903857UNII KVI301NA53UPC 0301153511017
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

N400115351101 followed by a unit qualifier and the quantity

Package 00115-3511-01. 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 .

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 0115-3511

What is NDC 0115-3511?
0115-3511 is the product NDC for Pyridostigmine Bromide, Pyridostigmine bromide 60 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pyridostigmine bromidePyridostigmine bromide 105 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC60846-55960846-0559-10
Pyridostigmine BromidePyridostigmine bromide 60 mg/1TabletOralMethod Pharmaceuticals, LLC58657-81158657-0811-0158657-0811-3058657-0811-90
Pyridostigmine BromidePyridostigmine bromide 60 mg/1TabletOralANI Pharmaceuticals, Inc.62559-47062559-0470-01
Pyridostigmine BromidePyridostigmine bromide 60 mg/5mLSolutionOralAcella Pharmaceuticals, LLC42192-62642192-0626-16
Pyridostigmine BromidePyridostigmine bromide 60 mg/5mLSolutionOralNovadoz Pharmaceuticals LLC72205-09872205-0098-72
Pyridostigmine BromidePyridostigmine bromide 30 mg/1TabletOralAmneal Pharmaceuticals of New York LLC0115-213400115-2134-01
Pyridostigmine BromidePyridostigmine bromide 60 mg/5mLSolutionOralAmneal Pharmaceuticals NY LLC69238-173169238-1731-02
Pyridostigmine BromidePyridostigmine bromide 60 mg/5mLSolutionOralVistaPharm, LLC66689-40666689-0406-10
Pyridostigmine BromidePyridostigmine bromide 30 mg/1TabletOralMethod Pharmaceuticals, LLC58657-81058657-0810-21
Pyridostigmine BromidePyridostigmine bromide 180 mg/1TabletOralRising Pharma Holdings, Inc.64980-22064980-0220-03

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
ProductStrengthForm · routeLabelerProduct NDC
Pyridostigmine BromidePyridostigmine bromide 30 mg/1TabletOralAmneal Pharmaceuticals of New York LLC0115-2134
Pyridostigmine BromidePyridostigmine bromide 60 mg/1TabletOralAmerican Health Packaging68084-494

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