Carglumic acid
- Product NDC
- 35573-459
- 11-digit product format
- 355730459
- Labeler code
- 35573
- Product ID
- 35573-459_28393de7-fa10-4e7d-919e-4d0b19c888a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carglumic acid
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA213395
- Marketing category
- ANDA
- Marketing start
- 2022-12-19
- Substance
- CARGLUMIC ACID
- Active strength
- 200 mg/1
- Pharmacologic classes
- Carbamoyl Phosphate Synthetase 1 Activator [EPC], Carbamoyl Phosphate Synthetase 1 Activators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carglumic acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARGLUMIC ACID | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5L0HB4V1EW |
| Rxcui | 905390 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35573-459-60 | Carglumic acid | 60 in 1 BOTTLE | TABLET, FOR SUSPENSION | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35573-459 | CARGLUMIC ACID TABLET, FOR SUSPENSION [BUREL PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240329_2aee4281-402b-4cd6-9e6a-08945262e1a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 35573-459-60 | 35573045960 | 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60) | 2022-12-19 | 0000-00-00 | No | No | Current |