Primidone NDC 55111-477

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-477Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0477Add 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
55111-477-01	55111047701	100 TABLET in 1 BOTTLE (55111-477-01)Marketed from Oct 3, 2008
55111-477-05	55111047705	500 TABLET in 1 BOTTLE (55111-477-05)Marketed from Oct 3, 2008
55111-477-30	55111047730	30 TABLET in 1 BOTTLE (55111-477-30)Marketed from Oct 3, 2008
55111-477-60	55111047760	60 TABLET in 1 BOTTLE (55111-477-60)Marketed from Oct 3, 2008
55111-477-78	55111047778	10 BLISTER PACK in 1 CARTON (55111-477-78) / 10 TABLET in 1 BLISTER PACK (55111-477-79)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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040862
Marketing start: Oct 3, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 55111-477_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

N455111047701 followed by a unit qualifier and the quantity

Package 55111-0477-01. 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)

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 250 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-476