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NDC 47335-0326-18 NALTREXONE HYDROCHLORIDE 50 mg/1 Details
NALTREXONE HYDROCHLORIDE 50 mg/1
NALTREXONE HYDROCHLORIDE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is NALTREXONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Naltrexone is used along with counseling and social support to help people who have stopped drinking alcohol and using street drugs continue to avoid drinking or using drugs. Naltrexone should not be used to treat people who are still using street drugs or drinking large amounts of alcohol. Naltrexone is in a class of medications called opiate antagonists. It works by decreasing the craving for alcohol and blocking the effects of opiate medications and opioid street drugs.
Related Packages: 47335-0326-18Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naltrexone
Product Information
| NDC | 47335-0326 |
|---|---|
| Product ID | 47335-326_b0c2b60a-dc96-483b-933e-2fed58b64372 |
| Associated GPIs | 93400030100305 |
| GCN Sequence Number | 004518 |
| GCN Sequence Number Description | naltrexone HCl TABLET 50 MG ORAL |
| HIC3 | H3T |
| HIC3 Description | OPIOID ANTAGONISTS |
| GCN | 17070 |
| HICL Sequence Number | 001875 |
| HICL Sequence Number Description | NALTREXONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | NALTREXONE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | NALTREXONE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | NALTREXONE HYDROCHLORIDE |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Pharmaceutical Class | Opioid Antagonist [EPC], Opioid Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090356 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 47335-0326-18 (47335032618)
| NDC Package Code | 47335-326-18 |
|---|---|
| Billing NDC | 47335032618 |
| Package | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18) |
| Marketing Start Date | 2012-02-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |