What is NDC 80005-117?

80005-117 is the product NDC for Primidone, Primidone 50 mg/1 tablet, listed with the FDA by Carnegie Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Carnegie Pharmaceuticals LLC, NDC labeler code 80005. 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 80005-117 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80005-117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80005-0117Add 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
80005-117-11	8000501171180005011711	100 TABLET in 1 BOTTLE (80005-117-11)Marketed from May 1, 2024
80005-117-14	8000501171480005011714	500 TABLET in 1 BOTTLE (80005-117-14)Marketed from May 1, 2024
80005-117-15	8000501171580005011715	1000 TABLET in 1 BOTTLE (80005-117-15)Marketed from May 1, 2024

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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Carnegie Pharmaceuticals LLCNDC labeler code 80005
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218366
Marketing start: May 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 80005-117_1f77f842-e0b6-4659-beee-0bb01da839e3SPL ID 1f77f842-e0b6-4659-beee-0bb01da839e3SPL set ID dc018b1d-72d3-45a2-84ff-cf9499c7ae97RxCUI 96304, 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

N480005011711 followed by a unit qualifier and the quantity

Package 80005-0117-11. 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 Jun 5, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Primidone tablets, 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)

About NDC 80005-117

What is NDC 80005-117?: 80005-117 is the product NDC for Primidone, Primidone 50 mg/1 tablet, listed with the FDA by Carnegie Pharmaceuticals LLC. It has 3 package NDCs, 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?: Carnegie Pharmaceuticals LLC, NDC labeler code 80005. 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 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
Primidone	Primidone 50 mg/1	TabletOral	DIRECT RX	72189-216	72189-0216-60

All 42 Primidone NDCs

Other NDCs under ANDA 218366

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

FDA NDC Directory listings under ANDA 218366
Product	Strength	Form · route	Labeler	Product NDC
Primidone	Primidone 250 mg/1	TabletOral	Carnegie Pharmaceuticals LLC	80005-118