Prescription drug · ANDA
Phenytoin NDC 0904-7199
Phenytoin 50 mg/1 · Tablet, Chewable · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7199-07 | 0090471990700904719907 | 30 BLISTER PACK in 1 CARTON (0904-7199-07) / 1 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Apr 17, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Phenytoin
- Generic name (nonproprietary)
- phenytoin
- Active ingredients
- Phenytoin — 50 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200565
- 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 0904-7199_066e29d5-dcad-4017-a345-085432105a41SPL ID 066e29d5-dcad-4017-a345-085432105a41SPL set ID 08a9d26b-4419-43ec-98f3-43d4534c2e76RxCUI 1313885UNII 6158TKW0C5
- 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
N400904719907followed by a unit qualifier and the quantityPackage 00904-7199-07. 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)
Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (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 0904-7199
- What is NDC 0904-7199?
- 0904-7199 is the product NDC for Phenytoin, Phenytoin 50 mg/1 tablet, chewable, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenytoin.
- What is the active ingredient?
- Phenytoin.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenytoin?
- 10 other product NDCs are listed under this name. See all Phenytoin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenytoin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Rising Pharma Holdings, Inc. | 64980-573 | 64980-0573-01 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | Mylan Pharmaceuticals Inc. | 59762-0531 | 59762-0531-02 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | American Health Packaging | 60687-275 | 60687-0275-66 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | REMEDYREPACK INC. | 70518-0841 | 70518-0841-0070518-0841-03 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | American Health Packaging | 60687-156 | 60687-0156-25 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8623 | 00615-8623-39 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Sun Pharmaceutical Industries, Inc. | 51672-4146 | 51672-4146-0151672-4146-0351672-4146-06 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0892 | 00121-0892-63 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-4070 | 17856-4070-01 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | Sun Pharmaceutical Industries, Inc. | 51672-4069 | 51672-4069-02 |
Other NDCs under ANDA 200565
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 | Phenytoin 50 mg/1 | Tablet, ChewableOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8623 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Sun Pharmaceutical Industries, Inc. | 51672-4146 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | American Health Packaging | 60687-156 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | REMEDYREPACK INC. | 70518-0841 |