Carglumic Acid
- Product NDC
- 70954-120
- 11-digit product format
- 709540120
- Labeler code
- 70954
- Product ID
- 70954-120_5c392737-44e7-45f1-bfc1-ec0cc017cdc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carglumic Acid
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA213729
- Marketing category
- ANDA
- Marketing start
- 2021-10-13
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70954-120-10 | 70954012010 | 1 BOTTLE in 1 CARTON (70954-120-10) > 60 TABLET, FOR SUSPENSION in 1 BOTTLE | 1 bottle | 2021-10-13 | 0000-00-00 | No | No | Current |