Levetiracetam
- Product NDC
- 17856-0865
- 11-digit product format
- 178560865
- Labeler code
- 17856
- Product ID
- 17856-0865_867f210f-d85c-4e78-b8a0-cf5d05416227
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corps
- Application
- ANDA079120
- Marketing category
- ANDA
- Marketing start
- 2009-01-16
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 76e81f18-c6b9-f226-530a-a6296d5cd5f4 | Product name | 6 | 20251106 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 087c9486-f4a9-a565-c6fb-d6fa49f4572a | Product name | 6 | 20230317 |
| 525a8d4d-1988-fc3f-e292-27fd384de4f0 | Product name | 8 | 20230104 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| 32b651f8-caa7-6882-11c7-54c4ad21796b | Product name | 8 | 20201216 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| ce453ca5-90cf-41ed-9de4-de519f70a0f2 | Product name | 2 | 20160303 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 66666eb8-1fa6-4a60-bae9-e564e73b4cd5 | Product name | 1 | 20150728 |
| eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477 | Product name | 1 | 20150410 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0865-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b3ef-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Levetiracetam Oral Solution safely and effectively. See full prescribing information for Levetiracetam Oral Solution. Levetiracetam 100 mg/mL Oral Solution Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0865-5 | Levetiracetam | 5 mL in 1 CUP | SOLUTION | 5 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| GRAPE | INACTIVE INGREDIENT | 6X543N684K | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| MALTITOL | INACTIVE INGREDIENT | D65DG142WK | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0865 | LEVETIRACETAM SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 2 | Legacy NDC, 1 package rows | 20120914_12552673-d561-49d7-9402-4100e5a56871.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403884 | levETIRAcetam 100 MG in 1 mL Oral Solution | PSN | 12552673-d561-49d7-9402-4100e5a56871 | 2 |
| 403884 | levetiracetam 100 MG/ML Oral Solution | SCD | 12552673-d561-49d7-9402-4100e5a56871 | 2 |
| 403884 | levetiracetam 100 MG per 1 ML Oral Solution | SY | 12552673-d561-49d7-9402-4100e5a56871 | 2 |
| 403884 | levetiracetam 1000 MG per 10 ML Oral Solution | SY | 12552673-d561-49d7-9402-4100e5a56871 | 2 |
| 403884 | levetiracetam 1500 MG per 15 ML Oral Solution | SY | 12552673-d561-49d7-9402-4100e5a56871 | 2 |
| 403884 | levetiracetam 500 MG per 5 ML Oral Solution | SY | 12552673-d561-49d7-9402-4100e5a56871 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 17856-0865-5 | 17856086505 | 5 mL in 1 CUP | 5 ml | Historical |