Levetiracetam
- Product NDC
- 16714-357
- 11-digit product format
- 167140357
- Labeler code
- 16714
- Product ID
- 16714-357_4d3e5006-b3fc-4987-a9a6-e15dceff384a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA078993
- Marketing category
- ANDA
- Marketing start
- 2009-01-15
- 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
- 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 |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-357 | LEVETIRACETAM TABLET, FILM COATED [NORTHSTAR RX LLC] | 22 | Legacy NDC | 20240723_e77eabc9-9f65-4d4b-8135-0290291e6ee8.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 |
|---|
| 16714-357-01 | 16714035701 | 60 TABLET, FILM COATED in 1 BOTTLE (16714-357-01) | 2009-01-15 | 0000-00-00 | No | No | Current |