Baclofen Injection
Product Images NDC 70511-121

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Baclofen (NDC 70511-121). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mala Pharmaceuticals, Inc., 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

Chemical-structrure (Baclofen Structure)

Chemical structure of baclofen, showing a chlorinated benzene ring bonded to an amino acid side chain with amino and carboxyl functional groups.*

FDA Label Image

Carton Label 5 Pack (Carton Label 5 Pack)

Label for Baclofen Injection (Intrathecal) 0.05 mg/mL (50 mcg/mL) sterile solution in 1 mL syringes. The label states it contains five 1 mL single-dose syringes. It includes instructions on the active ingredients per syringe, storage conditions, and manufacturer information. The labeler is MAlA Pharmaceuticals, Inc.*

FDA Label Image

Carton-label (Carton Label)

Baclofen Injection (Intrathecal) 0.05 mg/1 mL (50 mcg/mL) sterile solution for intrathecal injection only. Packaging includes one 1 mL single-dose syringe. Manufactured by MAlA Pharmaceuticals, Inc., labeled with NDC 70511-121-06. Storage instructions specify no refrigeration or freezing, with temperature range details. The label includes barcode and usage warnings.*

FDA Label Image

Syringe-label (Syringe Label)

Label for Baclofen Injection 0.05 mg/mL (50 mcg/mL) intrathecal injection. The label shows it is a sterile solution in a 1 mL single-dose prefilled syringe, manufactured for MAIA Pharmaceuticals, Inc. The label specifies the syringe's filled volumes and includes barcode and lot/expiration placeholders. The product is Rx only.*

FDA Label Image

Table 1 (Table 1)

A data table showing the incidence of the most frequent (≥1%) adverse events reported by patients with spasticity of spinal origin in clinical trials of Baclofen intrathecal injection, 50 ug/mL. The table categorizes the percent of patients experiencing each adverse event during screening (N=576), titration (N=474), and maintenance (N=430) phases.*

FDA Label Image

Table 2 (Table 2)

A data table titled 'Incidence of Most Frequent (≥1%) Adverse Events in Patients with Spasticity of Cerebral Origin in Prospectively Monitored Clinical Trials.' It lists adverse events and the percentage of patients reporting these events during screening, titration, and maintenance phases among three groups of 211, 153, and 150 patients respectively, following administration of Baclofen intrathecal injection.*

* 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.