Primidone NDC 52817-117

NDC codes

FDA NDC Directory

Product NDC (as listed)52817-117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52817-0117Add 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
52817-117-10	52817011710	100 TABLET in 1 BOTTLE (52817-117-10)Marketed from Feb 21, 2023
52817-117-30	52817011730	30 TABLET in 1 BOTTLE (52817-117-30)Marketed from Feb 21, 2023
52817-117-50	52817011750	500 TABLET in 1 BOTTLE (52817-117-50)Marketed from Feb 21, 2023

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): Primidone
Generic name (nonproprietary): primidone
Active ingredients: Primidone — 125 mg/1
Dosage form: Tablet
Route: Oral
Labeler: TruPharma LLC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214896
Marketing start: Jun 28, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 52817-117_f6667426-b68b-1ac7-e053-2a95a90a905bSPL ID f6667426-b68b-1ac7-e053-2a95a90a905bSPL set ID c60b3a92-4404-4a89-b2c5-c23ff72bedadRxCUI 328176UNII 13AFD7670QUPC 0352817117106, 0352817117502
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

N452817011710 followed by a unit qualifier and the quantity

Package 52817-0117-10. 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 8, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Primidone, used alone or concomitantly with other anticonvulsants, is 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)

Other NDCs under ANDA 214896

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

FDA NDC Directory listings under ANDA 214896
Product	Strength	Form · route	Labeler	Product NDC
Primidone	Primidone 50 mg/1	TabletOral	Advagen Pharma Limited	72888-045
Primidone	Primidone 250 mg/1	TabletOral	Advagen Pharma Limited	72888-046
Primidone	Primidone 50 mg/1	TabletOral	NorthStar Rx LLC	72603-609
Primidone	Primidone 250 mg/1	TabletOral	NorthStar Rx LLC	72603-610
Primidone	Primidone 125 mg/1	TabletOral	Advagen Pharma Limited	72888-160