Carglumic acid
- Product NDC
- 68475-006
- 11-digit product format
- 684750006
- Labeler code
- 68475
- Product ID
- 68475-006_55e79bd0-56bd-4095-aa7e-942b3e5c1b40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carglumic acid
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Navinta LLC
- Application
- ANDA213395
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- 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 |
|---|
| 68475-006-01 | Carglumic acid | 5 in 1 BOTTLE | TABLET, FOR SUSPENSION | 5 | | 3 |
| 68475-006-02 | Carglumic acid | 60 in 1 BOTTLE | TABLET, FOR SUSPENSION | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68475-006 | CARGLUMIC ACID TABLET, FOR SUSPENSION [NAVINTA LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240426_59e73eb8-edf8-4fad-93c2-deb6b23497f8.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 |
|---|
| 68475-006-01 | 68475000601 | 5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01) | 2022-08-01 | 0000-00-00 | No | No | Current |
| 68475-006-02 | 68475000602 | 60 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-02) | 2022-08-01 | 0000-00-00 | No | No | Current |