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NDC 61825-0165-30 DORAL 15 mg/1 Details
DORAL 15 mg/1
DORAL is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Galt Pharmaceuticals, LLC. The primary component is QUAZEPAM.
Product Information
| NDC | 61825-0165 |
|---|---|
| Product ID | 61825-165_f394815c-a01c-de75-e053-2995a90af184 |
| Associated GPIs | 60201028000310 |
| GCN Sequence Number | 003696 |
| GCN Sequence Number Description | quazepam TABLET 15 MG ORAL |
| HIC3 | H21 |
| HIC3 Description | SEDATIVE-HYPNOTICS - BENZODIAZEPINES |
| GCN | 40870 |
| HICL Sequence Number | 001595 |
| HICL Sequence Number Description | QUAZEPAM |
| Brand/Generic | Brand |
| Proprietary Name | DORAL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Quazepam |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | QUAZEPAM |
| Labeler Name | Galt Pharmaceuticals, LLC |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | NDA |
| Application Number | NDA018708 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 61825-0165-30 (61825016530)
| NDC Package Code | 61825-165-30 |
|---|---|
| Billing NDC | 61825016530 |
| Package | 30 TABLET in 1 BOTTLE (61825-165-30) |
| Marketing Start Date | 2018-12-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |