Prescription drug · ANDA
Dilantin (Extended phenytoin sodium) NDC 58151-110
Phenytoin sodium 100 mg/1 · Capsule, Extended release · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-110-01 | 5815101100158151011001 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01)Marketed from Dec 6, 2024 | |
| 58151-110-10 | 5815101101058151011010 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10)Marketed from Apr 9, 2025 | |
| 58151-110-88 | 5815101108858151011088 | 100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)Marketed from Dec 6, 2024 |
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)
- Dilantin
- Generic name (nonproprietary)
- extended phenytoin sodium
- Active ingredients
- Phenytoin sodium — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084349
- 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 58151-110_872f23a8-e6a3-4038-922d-0c26fc81d8b3SPL ID 872f23a8-e6a3-4038-922d-0c26fc81d8b3SPL set ID 86dd27d1-9cee-48ae-b55d-e2d2f7dbc593RxCUI 855671, 855673, 855869, 855871UNII 4182431BJHUPC 0358151118014, 0358151110018
- 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
N458151011001followed by a unit qualifier and the quantityPackage 58151-0110-01. 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 .
Indications (excerpt from the label)
DILANTIN is 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. DILANTIN is 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 58151-110
- What is NDC 58151-110?
- 58151-110 is the product NDC for Dilantin (extended phenytoin sodium), Phenytoin sodium 100 mg/1 capsule, extended release, listed with the FDA by Viatris Specialty LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dilantin (Extended Phenytoin Sodium).
- What is the active ingredient?
- Phenytoin sodium.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dilantin?
- 2 other product NDCs are listed under this name. See all Dilantin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dilantin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dilantinextended phenytoin sodium | Phenytoin sodium 30 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4325 | 70518-4325-00 |
| Dilantinextended phenytoin sodium | Phenytoin sodium 30 mg/1 | Capsule, Extended releaseOral | Viatris Specialty LLC | 58151-118 | 58151-0118-01 |
Other NDCs under ANDA 084349
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 |
|---|---|---|---|---|
| Dilantinextended phenytoin sodium | Phenytoin sodium 30 mg/1 | Capsule, Extended releaseOral | Viatris Specialty LLC | 58151-118 |
| Dilantinextended phenytoin sodium | Phenytoin sodium 30 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4325 |