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NDC 52652-6001-02 FLEQSUVY 5 mg/mL Details
FLEQSUVY 5 mg/mL
FLEQSUVY is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Azurity Pharmaceuticals, Inc.. The primary component is BACLOFEN.
Product Information
| NDC | 52652-6001 |
|---|---|
| Product ID | 52652-6001_a62deacf-f040-458c-83ca-0e7d39473c11 |
| Associated GPIs | 75100010001825 |
| GCN Sequence Number | 083047 |
| GCN Sequence Number Description | baclofen ORAL SUSP 25 MG/5 ML ORAL |
| HIC3 | H6H |
| HIC3 Description | SKELETAL MUSCLE RELAXANTS |
| GCN | 51885 |
| HICL Sequence Number | 001949 |
| HICL Sequence Number Description | BACLOFEN |
| Brand/Generic | Brand |
| Proprietary Name | FLEQSUVY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | baclofen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | BACLOFEN |
| Labeler Name | Azurity Pharmaceuticals, Inc. |
| Pharmaceutical Class | GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215602 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52652-6001-02 (52652600102)
| NDC Package Code | 52652-6001-2 |
|---|---|
| Billing NDC | 52652600102 |
| Package | 1 BOTTLE in 1 CARTON (52652-6001-2) / 300 mL in 1 BOTTLE |
| Marketing Start Date | 2022-02-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |