NDC codes

FDA NDC Directory
Product NDC (as listed)58657-810Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0810Add 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
58657-810-215865708102121 TABLET in 1 BOTTLE (58657-810-21)Marketed from Jun 1, 2019

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)
Pyridostigmine Bromide
Generic name (nonproprietary)
pyridostigmine bromide
Active ingredients
Pyridostigmine bromide — 30 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Method Pharmaceuticals, LLCNDC labeler code 58657
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211181
Marketing start
Listing expires
Other FDA classes
Cholinesterase Inhibitors (Mechanism)
Identifiers
Product ID 58657-810_41b66d64-08b1-bd0c-e063-6394a90a5b86SPL ID 41b66d64-08b1-bd0c-e063-6394a90a5b86SPL set ID e756717f-941b-42f2-ba3b-03798c005ae7RxCUI 903841UNII 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 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

N458657081021 followed by a unit qualifier and the quantity

Package 58657-0810-21. 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 58657-810

What is NDC 58657-810?
58657-810 is the product NDC for Pyridostigmine Bromide, Pyridostigmine bromide 30 mg/1 tablet, listed with the FDA by Method Pharmaceuticals, 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?
Method Pharmaceuticals, LLC, NDC labeler code 58657. 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 180 mg/1TabletOralRising Pharma Holdings, Inc.64980-22064980-0220-03
pyridostigmine bromidePyridostigmine bromide 60 mg/1TabletOralMajor Pharmaceuticals0904-662200904-6622-5900904-6622-61

All 18 Pyridostigmine Bromide NDCs

Other NDCs under ANDA 211181

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

FDA NDC Directory listings under ANDA 211181
ProductStrengthForm · routeLabelerProduct NDC
Pyridostigmine BromidePyridostigmine bromide 60 mg/1TabletOralMethod Pharmaceuticals, LLC58657-811

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