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NDC 63304-0048-30 Pregabalin 165 mg/1 Details
Pregabalin 165 mg/1
Pregabalin is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is PREGABALIN.
MedlinePlus Drug Summary
Pregabalin capsules, oral solution (liquid), and extended-release (long-acting) tablets are used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes and postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Pregabalin capsules and oral solution are also used to relieve neuropathic pain that can occur after a spinal cord injury and to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Pregabalin capsules and oral solution are used along with other medications to treat certain types of seizures in adults and children 1 month of age and older. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.
Related Packages: 63304-0048-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pregabalin
Product Information
| NDC | 63304-0048 |
|---|---|
| Product ID | 63304-048_50c7518b-349e-4284-ac0c-1ac2c332c3e4 |
| Associated GPIs | 62540060007530 |
| GCN Sequence Number | 077835 |
| GCN Sequence Number Description | pregabalin TAB ER 24H 165 MG ORAL |
| HIC3 | H5B |
| HIC3 Description | NEUROPATHIC AGENTS |
| GCN | 43987 |
| HICL Sequence Number | 026470 |
| HICL Sequence Number Description | PREGABALIN |
| Brand/Generic | Generic |
| Proprietary Name | Pregabalin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pregabalin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 165 |
| Active Ingredient Units | mg/1 |
| Substance Name | PREGABALIN |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | CV |
| Marketing Category | ANDA |
| Application Number | ANDA211889 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63304-0048-30 (63304004830)
| NDC Package Code | 63304-048-30 |
|---|---|
| Billing NDC | 63304004830 |
| Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-048-30) |
| Marketing Start Date | 2021-04-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |