Extended Phenytoin Sodium
- Product NDC
- 43063-492
- 11-digit product format
- 430630492
- Labeler code
- 43063
- Product ID
- 43063-492_db73d0d6-853a-11c6-e053-2a95a90a0f80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenytoin Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040765
- Marketing category
- ANDA
- Marketing start
- 2009-12-16
- Marketing end
- 0000-00-00
- Substance
- PHENYTOIN SODIUM
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENYTOIN SODIUM | ACTIVE INGREDIENT | 4182431BJH | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| PHENYTOIN | ACTIVE MOIETY | 6158TKW0C5 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-492 | EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 18 | Legacy NDC | 20241013_0666820e-9f59-4577-9e85-3454e80cba20.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-492-30 | 43063049230 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-492-30) | 30 capsule | 2012-04-25 | 0000-00-00 | No | No | Current |