Prescription drug · ANDA
Primidone NDC 62135-468
Primidone 50 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-468-90 | 6213504689062135046890 | 90 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
N462135046890followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Primidone products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 084903
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Primidone | Primidone 250 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1231 |
| 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 | 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 |