Phenytoin Sodium
- Product NDC
- 0615-8020
- 11-digit product format
- 006158020
- Labeler code
- 0615
- Product ID
- 0615-8020_57041ea1-a14e-483e-a41b-1bea65bb87ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA040684
- Marketing category
- ANDA
- Marketing start
- 2006-09-05
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN SODIUM
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8020 | PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 16 | Legacy NDC | 20240907_04ee6ba3-b086-4f28-9874-5728feebf677.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8020-30 | 00615802030 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8020-30) > 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK | 6 blister pack | 2006-09-05 | 0000-00-00 | No | No | Current |
| 0615-8020-39 | 00615802039 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8020-39) | | 2006-09-05 | 0000-00-00 | No | No | Current |