Search by Drug Name or NDC
NDC 00115-4433-03 Dantrolene Sodium 100 mg/1 Details
Dantrolene Sodium 100 mg/1
Dantrolene Sodium is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is DANTROLENE SODIUM.
MedlinePlus Drug Summary
Dantrolene is used to treat spasticity (muscle stiffness and tightness) or muscle spasms associated with spinal cord injuries, stroke, multiple sclerosis, or cerebral palsy. It is also used to prevent, treat, or reduce the risk of malignant hyperthermia (disorder that causes a fast rise in body temperature and muscle contractions), Dantrolene is in a class of medications called skeletal muscle relaxants. Dantrolene acts on the spinal cord nerves to treat spasticity and to prevent and treat malignant hyperthermia.
Related Packages: 00115-4433-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dantrolene
Product Information
| NDC | 00115-4433 |
|---|---|
| Product ID | 0115-4433_020cc0ba-19eb-4442-b55f-6820c32b4754 |
| Associated GPIs | 75200010100115 |
| GCN Sequence Number | 004666 |
| GCN Sequence Number Description | dantrolene sodium CAPSULE 100 MG ORAL |
| HIC3 | H6H |
| HIC3 Description | SKELETAL MUSCLE RELAXANTS |
| GCN | 17940 |
| HICL Sequence Number | 001947 |
| HICL Sequence Number Description | DANTROLENE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Dantrolene Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dantrolene Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | DANTROLENE SODIUM |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Pharmaceutical Class | Decreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076856 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00115-4433-03 (00115443303)
| NDC Package Code | 0115-4433-03 |
|---|---|
| Billing NDC | 00115443303 |
| Package | 1000 CAPSULE in 1 BOTTLE (0115-4433-03) |
| Marketing Start Date | 2005-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |