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NDC 52427-0804-60 Gralise 450 mg/1 Details
Gralise 450 mg/1
Gralise is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Almatica Pharma LLC. The primary component is GABAPENTIN.
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: 52427-0804-60Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Gabapentin
Product Information
| NDC | 52427-0804 |
|---|---|
| Product ID | 52427-804_7881acf0-5f3c-861a-ca44-b82bd0323dd7 |
| Associated GPIs | |
| GCN Sequence Number | 084667 |
| GCN Sequence Number Description | gabapentin TAB ER 24H 450 MG ORAL |
| HIC3 | H0D |
| HIC3 Description | POSTHERPETIC NEURALGIA AGENTS |
| GCN | 54018 |
| HICL Sequence Number | 008831 |
| HICL Sequence Number Description | GABAPENTIN |
| Brand/Generic | Brand |
| Proprietary Name | Gralise |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | gabapentin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 450 |
| Active Ingredient Units | mg/1 |
| Substance Name | GABAPENTIN |
| Labeler Name | Almatica Pharma LLC |
| Pharmaceutical Class | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022544 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52427-0804-60 (52427080460)
| NDC Package Code | 52427-804-60 |
|---|---|
| Billing NDC | 52427080460 |
| Package | 60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60) |
| Marketing Start Date | 2023-04-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |