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NDC 53451-0103-09 Horizant 300 mg/1 Details
Horizant 300 mg/1
Horizant is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals). The primary component is GABAPENTIN ENACARBIL.
MedlinePlus Drug Summary
Gabapentin capsules, tablets, and oral solution are used along with other medications to help control certain types of seizures in people who have epilepsy. Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain. It is not known exactly how gabapentin works to treat restless legs syndrome.
Related Packages: 53451-0103-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Gabapentin
Product Information
| NDC | 53451-0103 |
|---|---|
| Product ID | 53451-0103_5b1d346e-2db1-4c2a-baf5-a4598642a4e7 |
| Associated GPIs | 62560030200420 |
| GCN Sequence Number | 071827 |
| GCN Sequence Number Description | gabapentin enacarbil TABLET ER 300 MG ORAL |
| HIC3 | H6L |
| HIC3 Description | DRUGS TO TREAT MOVEMENT DISORDERS |
| GCN | 35819 |
| HICL Sequence Number | 037574 |
| HICL Sequence Number Description | GABAPENTIN ENACARBIL |
| Brand/Generic | Brand |
| Proprietary Name | Horizant |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | gabapentin enacarbil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | GABAPENTIN ENACARBIL |
| Labeler Name | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) |
| Pharmaceutical Class | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022399 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53451-0103-09 (53451010309)
| NDC Package Code | 53451-0103-9 |
|---|---|
| Billing NDC | 53451010309 |
| Package | 5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-9) |
| Marketing Start Date | 2013-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |