What is NDC 0527-1231?

0527-1231 is the product NDC for Primidone, Primidone 250 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. 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 0527-1231 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1231Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1231Add 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
0527-1231-01	0052712310100527123101	100 TABLET in 1 BOTTLE (0527-1231-01)Marketed from Dec 1, 1978
0527-1231-05	0052712310500527123105	500 TABLET in 1 BOTTLE (0527-1231-05)Marketed from Dec 1, 1978
0527-1231-10	0052712311000527123110	1000 TABLET in 1 BOTTLE (0527-1231-10)Marketed from Dec 1, 1978

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 — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084903
Marketing start: Dec 1, 1978
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0527-1231_99bd0a67-2742-43dd-9ddc-430b9141c3b1SPL ID 99bd0a67-2742-43dd-9ddc-430b9141c3b1SPL set ID a1a817f7-c190-4825-94eb-442f477187e3RxCUI 96304, 198150UNII 13AFD7670QUPC 0305871231011
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

N400527123101 followed by a unit qualifier and the quantity

Package 00527-1231-01. 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 Jun 11, 2020.

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)

About NDC 0527-1231

What is NDC 0527-1231?: 0527-1231 is the product NDC for Primidone, Primidone 250 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. 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?: Lannett Company, Inc., NDC labeler code 0527. 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 084903

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

FDA NDC Directory listings under ANDA 084903
Product	Strength	Form · route	Labeler	Product NDC
Primidone	Primidone 50 mg/1	TabletOral	Lannett Company, Inc.	0527-1301
Primidone	Primidone 50 mg/1	TabletOral	Golden State Medical Supply, Inc	51407-637
Primidone	Primidone 250 mg/1	TabletOral	Golden State Medical Supply, Inc	51407-638
Primidone	Primidone 50 mg/1	TabletOral	Chartwell RX, LLC	62135-468
Primidone	Primidone 50 mg/1	TabletOral	American Health Packaging	68084-202
Primidone	Primidone 250 mg/1	TabletOral	American Health Packaging	68084-203
Primidone	Primidone 50 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-763