What is NDC 68382-659?

68382-659 is the product NDC for pyridostigmine bromide, Pyridostigmine bromide 60 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 68382-659 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-659Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0659Add 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
68382-659-01	68382065901	100 TABLET in 1 BOTTLE (68382-659-01)Marketed from Aug 7, 2015
68382-659-05	68382065905	500 TABLET in 1 BOTTLE (68382-659-05)Marketed from Aug 7, 2015
68382-659-06	68382065906	30 TABLET in 1 BOTTLE (68382-659-06)Marketed from Aug 7, 2015
68382-659-16	68382065916	90 TABLET in 1 BOTTLE (68382-659-16)Marketed from Aug 7, 2015

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: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205650
Marketing start: Aug 7, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Cholinesterase Inhibitors (Mechanism)
Identifiers: Product ID 68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907SPL ID 5439e6be-2d67-4bbd-b72f-3364cb62f907SPL set ID 44e8c2dd-3931-4508-9fa7-5a660d6dfddbRxCUI 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

N468382065901 followed by a unit qualifier and the quantity

Package 68382-0659-01. 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 Nov 7, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Pyridostigmine bromide tablets, USP 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 68382-659

What is NDC 68382-659?: 68382-659 is the product NDC for pyridostigmine bromide, Pyridostigmine bromide 60 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 4 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?: Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 30 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-2134	00115-2134-01
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

All 18 pyridostigmine bromide NDCs

Other NDCs under ANDA 205650

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

FDA NDC Directory listings under ANDA 205650
Product	Strength	Form · route	Labeler	Product NDC
pyridostigmine bromide	Pyridostigmine bromide 60 mg/1	TabletOral	Major Pharmaceuticals	0904-6622
pyridostigmine bromide	Pyridostigmine bromide 60 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-590
pyridostigmine bromide	Pyridostigmine bromide 60 mg/1	TabletOral	Zydus Lifesciences Limited	65841-819