Prescription drug · ANDA
Extended Phenytoin Sodium (Phenytoin sodium) NDC 65162-212
Phenytoin sodium 100 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-212-03 | 6516202120365162021203 | 30 CAPSULE in 1 BOTTLE (65162-212-03)Marketed from Dec 16, 2009 | |
| 65162-212-10 | 6516202121065162021210 | 100 CAPSULE in 1 BOTTLE (65162-212-10)Marketed from Dec 16, 2009 | |
| 65162-212-11 | 6516202121165162021211 | 1000 CAPSULE in 1 BOTTLE (65162-212-11)Marketed from Dec 16, 2009 | |
| 65162-212-50 | 6516202125065162021250 | 500 CAPSULE in 1 BOTTLE (65162-212-50)Marketed from Dec 16, 2009 |
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)
- Extended Phenytoin Sodium
- Generic name (nonproprietary)
- phenytoin sodium
- Active ingredients
- Phenytoin sodium — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040765
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65162-212_c611611f-fb3d-40e8-8c1c-dcb6554aaa41SPL ID c611611f-fb3d-40e8-8c1c-dcb6554aaa41SPL set ID 7e467c02-49a0-4b62-b537-430fdfa4f10eRxCUI 855671UNII 4182431BJHUPC 0365162212037, 0365162212105
- 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
N465162021203followed by a unit qualifier and the quantityPackage 65162-0212-03. 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)
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (1)
Excerpt only. Read the full label for complete information.
About NDC 65162-212
- What is NDC 65162-212?
- 65162-212 is the product NDC for Extended Phenytoin Sodium (phenytoin sodium), Phenytoin sodium 100 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Extended Phenytoin Sodium (Phenytoin Sodium).
- What is the active ingredient?
- Phenytoin sodium.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Extended Phenytoin Sodium?
- 5 other product NDCs are listed under this name. See all Extended Phenytoin Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Extended Phenytoin Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Extended Phenytoin Sodiumphenytoin sodium | Phenytoin sodium 100 mg/1 | CapsuleOral | American Health Packaging | 60687-841 | 60687-0841-01 |
| Extended Phenytoin Sodiumphenytoin sodium | Phenytoin sodium 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2227 | 70518-2227-03 |
| Extended Phenytoin Sodiumphenytoin sodium | Phenytoin sodium 100 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8556 | 00615-8556-39 |
| Extended Phenytoin Sodiumphenytoin sodium | Phenytoin sodium 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-692 | 65862-0692-0165862-0692-7865862-0692-99 |
| Extended Phenytoin Sodiumphenytoin sodium | Phenytoin sodium 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2514 | 72162-2514-0072162-2514-01 |
Other NDCs under ANDA 040765
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 |
|---|---|---|---|---|
| Phenytoin Sodium | Phenytoin sodium 100 mg/1 | CapsuleOral | DIRECT RX | 61919-815 |