Levetiracetam
- Product NDC
- 65977-5038
- 11-digit product format
- 659775038
- Labeler code
- 65977
- Product ID
- 65977-5038_b9acd365-1b80-4428-bd33-3a5eac814677
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hetero Drugs Ltd.,
- Application
- ANDA090515
- Marketing category
- ANDA
- Marketing start
- 2010-10-08
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 750 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65977-5038-0 | Levetiracetam | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 65977-5038-1 | Levetiracetam | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 65977-5038-2 | Levetiracetam | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
| 65977-5038-3 | Levetiracetam | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| Polyvinyl Alcohol | INACTIVE INGREDIENT | 532B59J990 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65977-5038 | LEVETIRACETAM TABLET, FILM COATED [HETERO DRUGS LTD.,] | 1 | Legacy NDC, 4 package rows | 20110404_b9acd365-1b80-4428-bd33-3a5eac814677.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 65977-5038-0 | 65977503800 | 30 in 1 BOTTLE | Historical |
| 65977-5038-1 | 65977503801 | 60 in 1 BOTTLE | Historical |
| 65977-5038-2 | 65977503802 | 120 in 1 BOTTLE | Historical |
| 65977-5038-3 | 65977503803 | 500 in 1 BOTTLE | Historical |