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NDC 71225-0140-01 BACLOFEN 5 mg/mL Details
BACLOFEN 5 mg/mL
BACLOFEN is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Slayback Pharma LLC. The primary component is BACLOFEN.
Product Information
| NDC | 71225-0140 |
|---|---|
| Product ID | 71225-140_f948e217-c9bb-4ec1-b5fb-864cc14afe4e |
| Associated GPIs | |
| 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 | Generic |
| Proprietary Name | BACLOFEN |
| 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 | Slayback Pharma LLC |
| Pharmaceutical Class | GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA217252 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71225-0140-01 (71225014001)
| NDC Package Code | 71225-140-01 |
|---|---|
| Billing NDC | 71225014001 |
| Package | 1 BOTTLE in 1 CARTON (71225-140-01) / 250 mL in 1 BOTTLE |
| Marketing Start Date | 2023-06-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |