NDC codes

FDA NDC Directory
Product NDC (as listed)62135-468Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0468Add 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 NDC11-digit (billing)PackageCopy
62135-468-90621350468906213504689090 TABLET in 1 BOTTLE (62135-468-90)Marketed from Apr 11, 2023

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
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 084903
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 62135-468_45ae0446-2685-d868-e063-6394a90ab581SPL ID 45ae0446-2685-d868-e063-6394a90ab581SPL set ID 4a8e309f-d89e-4b1a-abb2-856a66ebbff9RxCUI 198150UNII 13AFD7670QUPC 0362135468903
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

N462135046890 followed by a unit qualifier and the quantity

Package 62135-0468-90. 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 .

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 62135-468

What is NDC 62135-468?
62135-468 is the product NDC for Primidone, Primidone 50 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. 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?
Chartwell RX, LLC, NDC labeler code 62135. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PrimidonePrimidone 50 mg/1TabletOralNorthStar Rx LLC72603-60972603-0609-0172603-0609-02
PrimidonePrimidone 250 mg/1TabletOralNorthStar Rx LLC72603-61072603-0610-01
PrimidonePrimidone 50 mg/1TabletOralCarnegie Pharmaceuticals LLC80005-11780005-0117-1180005-0117-1480005-0117-15
PrimidonePrimidone 250 mg/1TabletOralCarnegie Pharmaceuticals LLC80005-11880005-0118-1180005-0118-1480005-0118-15
PrimidonePrimidone 50 mg/1TabletOralAdvagen Pharma Limited72888-04572888-0045-0172888-0045-05
PrimidonePrimidone 250 mg/1TabletOralAdvagen Pharma Limited72888-04672888-0046-0172888-0046-05
PrimidonePrimidone 125 mg/1TabletOralAdvagen Pharma Limited72888-16072888-0160-0072888-0160-0172888-0160-05+1 more
PrimidonePrimidone 125 mg/1TabletOralTruPharma LLC.52817-11752817-0117-1052817-0117-3052817-0117-50
PrimidonePrimidone 50 mg/1TabletOralAvKARE42291-50942291-0509-50
PrimidonePrimidone 250 mg/1TabletOralAvKARE42291-51142291-0511-01

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
ProductStrengthForm · routeLabelerProduct NDC
PrimidonePrimidone 250 mg/1TabletOralLannett Company, Inc.0527-1231
PrimidonePrimidone 50 mg/1TabletOralLannett Company, Inc.0527-1301
PrimidonePrimidone 50 mg/1TabletOralGolden State Medical Supply, Inc51407-637
PrimidonePrimidone 250 mg/1TabletOralGolden State Medical Supply, Inc51407-638
PrimidonePrimidone 50 mg/1TabletOralAmerican Health Packaging68084-202
PrimidonePrimidone 250 mg/1TabletOralAmerican Health Packaging68084-203
PrimidonePrimidone 50 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-763

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