Levetiracetam
- Product NDC
- 65862-315
- 11-digit product format
- 658620315
- Labeler code
- 65862
- Product ID
- 65862-315_61244070-03c7-41d1-a784-b46dfc93fcbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078993
- Marketing category
- ANDA
- Marketing start
- 2009-01-15
- Substance
- LEVETIRACETAM
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 311288, 311289, 311290, 387003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-315-05 | Levetiracetam | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 29 |
| 65862-315-30 | Levetiracetam | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 29 |
| 65862-315-60 | Levetiracetam | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 29 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-315 | LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 29 | Current NDC, Legacy NDC, 3 package rows | 20240406_2471ee03-d747-4113-86d0-1aa93c8f3eba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-315-05 | 65862031505 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-315-05) | 2009-01-15 | 0000-00-00 | No | No | Current |
| 65862-315-30 | 65862031530 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-315-30) | 2009-01-15 | 0000-00-00 | No | No | Current |
| 65862-315-60 | 65862031560 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-315-60) | 2009-01-15 | 0000-00-00 | No | No | Current |