Search by Drug Name or NDC
NDC 00054-0137-49 Galantamine Hydrobromide 4 mg/mL Details
Galantamine Hydrobromide 4 mg/mL
Galantamine Hydrobromide is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is GALANTAMINE HYDROBROMIDE.
MedlinePlus Drug Summary
Galantamine is used to treat the symptoms of Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Galantamine is in a class of medications called acetylcholinesterase inhibitors. It works by increasing the amount of a certain natural substance in the brain that is needed for memory and thought. Galantamine may improve the ability to think and remember or slow the loss of these abilities in people who have AD. However, galantamine will not cure AD or prevent the loss of mental abilities at some time in the future.
Related Packages: 00054-0137-49Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Galantamine
Product Information
| NDC | 00054-0137 |
|---|---|
| Product ID | 0054-0137_b2bf3efc-7521-4ff7-b77c-6e312e34b3c4 |
| Associated GPIs | 62051030102020 |
| GCN Sequence Number | 048437 |
| GCN Sequence Number Description | galantamine HBr SOLUTION 4 MG/ML ORAL |
| HIC3 | J1B |
| HIC3 Description | CHOLINESTERASE INHIBITORS |
| GCN | 13898 |
| HICL Sequence Number | 016520 |
| HICL Sequence Number Description | GALANTAMINE HBR |
| Brand/Generic | Generic |
| Proprietary Name | Galantamine Hydrobromide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Galantamine Hydrobromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | mg/mL |
| Substance Name | GALANTAMINE HYDROBROMIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078185 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00054-0137-49 (00054013749)
| NDC Package Code | 0054-0137-49 |
|---|---|
| Billing NDC | 00054013749 |
| Package | 100 mL in 1 BOTTLE (0054-0137-49) |
| Marketing Start Date | 2009-08-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |