Extended Phenytoin Sodium
- Product NDC
- 71610-479
- 11-digit product format
- 716100479
- Labeler code
- 71610
- Product ID
- 71610-479_444cd2c3-a0d4-4c73-b74e-284a212f288b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040765
- Marketing category
- ANDA
- Marketing start
- 2020-08-25
- 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
- 2021-12-31
- 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 |
|---|
| 71610-479 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20201113_f163208c-25e7-415b-ae17-9f5f5870e6e8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-479-60 | 71610047960 | 90 CAPSULE in 1 BOTTLE (71610-479-60) | 90 capsule | 2020-11-02 | 0000-00-00 | No | No | Current |
| 71610-479-70 | 71610047970 | 120 CAPSULE in 1 BOTTLE (71610-479-70) | 120 capsule | 2020-11-02 | 0000-00-00 | No | No | Current |
| 71610-479-92 | 71610047992 | 270 CAPSULE in 1 BOTTLE (71610-479-92) | 270 capsule | 2020-11-02 | 0000-00-00 | No | No | Current |
| 71610-479-94 | 71610047994 | 360 CAPSULE in 1 BOTTLE (71610-479-94) | 360 capsule | 2020-11-02 | 0000-00-00 | No | No | Current |
| 71610-479-98 | 71610047998 | 540 CAPSULE in 1 BOTTLE (71610-479-98) | 540 capsule | 2020-11-02 | 0000-00-00 | No | No | Current |