Elepsia XR
- Product NDC
- 47133-574
- 11-digit product format
- 471330574
- Labeler code
- 47133
- Product ID
- 47133-574_be26dd04-d8a3-42c3-ab44-210dff9a0e3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharma Advanced Research Company Limited
- Application
- NDA204417
- Marketing category
- NDA
- Marketing start
- 2019-05-17
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | INACTIVE INGREDIENT | 905HNO1SIH | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47133-574 | ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED] | 9 | Legacy NDC | 20210108_12e147dc-4f5b-4117-8a8e-a8c429ad0217.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47133-574-13 | 47133057413 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-574-13) | 2019-05-17 | 0000-00-00 | No | No | Current |
| 47133-574-83 | 47133057483 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-574-83) | 2019-05-17 | 0000-00-00 | No | No | Current |
| 47133-574-88 | 47133057488 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-574-88) | 2019-05-17 | 0000-00-00 | No | No | Current |