NDC codes

FDA NDC Directory
Product NDC (as listed)68084-494Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0494Add 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
68084-494-0168084049401100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-494-01) / 1 TABLET in 1 BLISTER PACK (68084-494-11)Marketed from Oct 4, 2011

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 — 60 mg/1
Dosage form
Tablet
Route
Oral
Labeler
American Health PackagingNDC labeler code 68084
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 68084-494_386b22b2-6b00-f2c0-e063-6394a90a0d43SPL ID 386b22b2-6b00-f2c0-e063-6394a90a0d43SPL set ID 30cb0b9f-e308-4501-90c2-b17349c048b7RxCUI 903857UNII 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

N468084049401 followed by a unit qualifier and the quantity

Package 68084-0494-01. 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 68084-494

What is NDC 68084-494?
68084-494 is the product NDC for Pyridostigmine Bromide, Pyridostigmine bromide 60 mg/1 tablet, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 68084. 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?
18 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 19 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/1TabletOralAmneal Pharmaceuticals of New York LLC0115-3511

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