What is NDC 72189-216?

72189-216 is the product NDC for Primidone, Primidone 50 mg/1 tablet, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.

DIRECT RX, NDC labeler code 72189. 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 72189-216 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0216Add 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
72189-216-60	7218902166072189021660	60 TABLET in 1 BOTTLE (72189-216-60)Marketed from May 11, 2021

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: DIRECT RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040586
Marketing start: May 11, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 72189-216_2be9877c-0b1e-23b4-e063-6394a90af68fSPL ID 2be9877c-0b1e-23b4-e063-6394a90af68fSPL set ID c20f803c-e965-9dd8-e053-2995a90a92baRxCUI 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

N472189021660 followed by a unit qualifier and the quantity

Package 72189-0216-60. 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 Jan 17, 2025.

Indications (excerpt from the label)

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 72189-216

What is NDC 72189-216?: 72189-216 is the product NDC for Primidone, Primidone 50 mg/1 tablet, listed with the FDA by DIRECT RX. 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?: DIRECT RX, NDC labeler code 72189. 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 040586

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

FDA NDC Directory listings under ANDA 040586
Product	Strength	Form · route	Labeler	Product NDC
Primidone	Primidone 50 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8664
Primidone	Primidone 50 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-684
Primidone	Primidone 250 mg/1	TabletOral	Oxford Pharmaceuticals, LLC	69584-685
Primidone	Primidone 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-1965
Primidone	Primidone 50 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-540
Primidone	Primidone 50 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-590
Primidone	Primidone 250 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-177
Primidone	Primidone 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-178
Primidone	Primidone 50 mg/1	TabletOral	Proficient Rx LP	82804-952
Primidone	Primidone 250 mg/1	TabletOral	Proficient Rx LP	82804-953