Carglumic Acid Tablet, For Suspension
Product Images NDC 68475-006

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Carglumic Acid (NDC 68475-006). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Navinta Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

1 (99df9818 313d 42a4 A5c3 Bfa1d3b6f638 01)

Label for Carglumic Acid Tablets for Oral Suspension 200 mg, 5 tablets, by Navinta LLC. The label includes storage instructions at 20° to 25°C, a barcode, and a note to discard one month after first opening. It also provides space to record the date of first opening and states the product is Rx only.*

FDA Label Image

2 (99df9818 313d 42a4 A5c3 Bfa1d3b6f638 02)

Packaging label for Carglumic Acid Tablets for Oral Suspension 200 mg by Navinta LLC. The label indicates the product contains 5 tablets, is for oral suspension, and must be dispersed in water before use. The label includes storage instructions, dosage administration notes, and a barcode. Manufactured in India for Navinta LLC, Ewing, NJ.*

FDA Label Image

3 (99df9818 313d 42a4 A5c3 Bfa1d3b6f638 03)

Label for Carglumic Acid Tablets for Oral Suspension, 200 mg strength. The label includes handling and storage instructions, a barcode, and states the product is manufactured for Navinta LLC. It indicates a package count of 60 tablets and specifies Rx only. The label also has a space for recording the date of first opening.*

FDA Label Image

4 (99df9818 313d 42a4 A5c3 Bfa1d3b6f638 04)

Packaging label for Carglumic Acid Tablets for Oral Suspension 200 mg, containing 60 tablets. The tablets are white to off-white, elongated, and functionally scored for splitting. Label indicates storage instructions and usage warnings. Manufactured for Navinta LLC, Ewing, NJ, with NDC 68475-006-02.*

FDA Label Image

Image (99df9818 313d 42a4 A5c3 Bfa1d3b6f638 195 1)

Chemical structure diagram showing the molecular structure of carglumic acid, the active ingredient in the product. The diagram highlights the arrangement of atoms, including amine, carboxyl, and hydroxyl functional groups, consistent with carglumic acid's chemical composition.*

FDA Label Image

Image (99df9818 313d 42a4 A5c3 Bfa1d3b6f638 220 1)

A line chart titled 'NH3 response (evaluable patients n=13)' showing mean ammonia (NH3) levels in µmol/L over time from Baseline through Days 2, 4, 5, 6, 7, and Long-term. The graph illustrates a sharp decline in mean NH3 levels from nearly 275 µmol/L at Baseline to below 50 µmol/L by Day 2, then relatively stable lower levels across subsequent days and long-term.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.