Search by Drug Name or NDC
NDC 35573-0459-60 Carglumic acid 200 mg/1 Details
Carglumic acid 200 mg/1
Carglumic acid is a ORAL TABLET, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Burel Pharmaceuticals, LLC. The primary component is CARGLUMIC ACID.
Product Information
| NDC | 35573-0459 |
|---|---|
| Product ID | 35573-459_5d8ac14d-dd85-4d80-9e3d-07a52e1f72ab |
| Associated GPIs | |
| GCN Sequence Number | 053150 |
| GCN Sequence Number Description | carglumic acid TAB DISPER 200 MG ORAL |
| HIC3 | D9A |
| HIC3 Description | AMMONIA INHIBITORS |
| GCN | 20522 |
| HICL Sequence Number | 025643 |
| HICL Sequence Number Description | CARGLUMIC ACID |
| Brand/Generic | Generic |
| Proprietary Name | Carglumic acid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Carglumic acid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | CARGLUMIC ACID |
| Labeler Name | Burel Pharmaceuticals, LLC |
| Pharmaceutical Class | Carbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213395 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 35573-0459-60 (35573045960)
| NDC Package Code | 35573-459-60 |
|---|---|
| Billing NDC | 35573045960 |
| Package | 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60) |
| Marketing Start Date | 2022-12-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |