What is NDC 55111-476?

55111-476 is the product NDC for Primidone, Primidone 250 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 55111-476 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-476Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0476Add 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
55111-476-01	5511104760155111047601	100 TABLET in 1 BOTTLE (55111-476-01)Marketed from Oct 3, 2008
55111-476-05	5511104760555111047605	500 TABLET in 1 BOTTLE (55111-476-05)Marketed from Oct 3, 2008
55111-476-30	5511104763055111047630	30 TABLET in 1 BOTTLE (55111-476-30)Marketed from Oct 3, 2008
55111-476-60	5511104766055111047660	60 TABLET in 1 BOTTLE (55111-476-60)Marketed from Oct 3, 2008
55111-476-78	5511104767855111047678	10 BLISTER PACK in 1 CARTON (55111-476-78) / 10 TABLET in 1 BLISTER PACK (55111-476-79)Marketed from Oct 3, 2008

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 — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040862
Marketing start: Oct 3, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 55111-476_6f5c36d3-3f99-803c-5be6-66b2e1058946SPL ID 6f5c36d3-3f99-803c-5be6-66b2e1058946SPL set ID a4f917f4-2aa2-c3ed-071e-232fa0f125e8RxCUI 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

N455111047601 followed by a unit qualifier and the quantity

Package 55111-0476-01. 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 Dec 2, 2010.

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 55111-476

What is NDC 55111-476?: 55111-476 is the product NDC for Primidone, Primidone 250 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 5 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?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 040862

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

FDA NDC Directory listings under ANDA 040862
Product	Strength	Form · route	Labeler	Product NDC
Primidone	Primidone 50 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-477