What is NDC 0615-8206?

0615-8206 is the product NDC for Primidone, Primidone 50 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Primidone?

41 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Primidone NDC 0615-8206 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8206Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8206Add 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
0615-8206-39	0061582063900615820639	30 TABLET in 1 BLISTER PACK (0615-8206-39)Marketed from Apr 5, 2018

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): Primidone
Generic name (nonproprietary): primidone
Active ingredients: Primidone — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040866
Marketing start: Dec 24, 2009
Marketing end: May 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0615-8206_93dbaa1a-4b78-4c4d-a017-36d9736a4145SPL ID 93dbaa1a-4b78-4c4d-a017-36d9736a4145SPL set ID 1c56d09c-4224-4875-bb22-e8bfd595d378RxCUI 198150UNII 13AFD7670Q
Pharmacologic class: Anti-epileptic Agent

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

N400615820639 followed by a unit qualifier and the quantity

Package 00615-8206-39. 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 Mar 3, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Primidone tablets used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8206

What is NDC 0615-8206?: 0615-8206 is the product NDC for Primidone, Primidone 50 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Primidone.
What is the active ingredient?: Primidone.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Primidone?: 41 other product NDCs are listed under this name. See all Primidone 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 Primidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Primidone	Primidone 50 mg/1	TabletOral	NorthStar Rx LLC	72603-609	72603-0609-0172603-0609-02
Primidone	Primidone 250 mg/1	TabletOral	NorthStar Rx LLC	72603-610	72603-0610-01
Primidone	Primidone 50 mg/1	TabletOral	Carnegie Pharmaceuticals LLC	80005-117	80005-0117-1180005-0117-1480005-0117-15
Primidone	Primidone 250 mg/1	TabletOral	Carnegie Pharmaceuticals LLC	80005-118	80005-0118-1180005-0118-1480005-0118-15
Primidone	Primidone 50 mg/1	TabletOral	Advagen Pharma Limited	72888-045	72888-0045-0172888-0045-05
Primidone	Primidone 250 mg/1	TabletOral	Advagen Pharma Limited	72888-046	72888-0046-0172888-0046-05
Primidone	Primidone 125 mg/1	TabletOral	Advagen Pharma Limited	72888-160	72888-0160-0072888-0160-0172888-0160-05+1 more
Primidone	Primidone 125 mg/1	TabletOral	TruPharma LLC.	52817-117	52817-0117-1052817-0117-3052817-0117-50
Primidone	Primidone 50 mg/1	TabletOral	AvKARE	42291-509	42291-0509-50
Primidone	Primidone 250 mg/1	TabletOral	AvKARE	42291-511	42291-0511-01

All 42 Primidone NDCs

Other NDCs under ANDA 040866

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

FDA NDC Directory listings under ANDA 040866
Product	Strength	Form · route	Labeler	Product NDC
Primidone	Primidone 250 mg/1	TabletOral	AvPAK	50268-687
Primidone	Primidone 50 mg/1	TabletOral	AvPAK	50268-686
Primidone	Primidone 50 mg/1	TabletOral	Bryant Ranch Prepack	63629-7811
Primidone	Primidone 50 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-544
Primidone	Primidone 250 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-545
Primidone	Primidone 250 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-545
Primidone	Primidone 50 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-544
Primidone	Primidone 50 mg/1	TabletOral	AvKARE	42291-509
Primidone	Primidone 250 mg/1	TabletOral	AvKARE	42291-511