Material Name: Gabapentin Capsules (100 mg, 300 mg and 400 mg) Trade Name: NEURONTIN; NEUGABA; GANTIN; PARKETIN; GABAPENTIN PFIZER Chemical Family: Mixture Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use: Pharmaceutical product used as anticonvulsant Details of the Supplier of the Safety Data Sheet 2. Generic Name: Gabapentin Capsules, USP 100, 300 and 400 mg. Brand Equivalent: Neurontin® (Gabapentin) Capsules, 100/300 and 400 mg SECTION 1: IDENTIFICATION Show this safety data sheet to the doctor in attendance. Immediate medical attention is required. Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice. MATERIAL SAFETY DATA SHEET. Gabapentin Capsules, USP . Effective Date: 04-26-2010 . Section 1 - Chemical Product and Company . Manufacturer: Emergency Phone: InvaGen Pharmaceuticals Inc 1-631-231-3233 7, Oser Avenue . Hauppauge, NY 11788 . Common Name: Gabapentin Capsules, USP . Synonym(s): Neurontin Chemical Name: 1-(Aminomethyl Gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice (e.g., spinal nerve ligation models, spinal cord injury model, acute herpes zoster infection model). 400 mg capsules: Hard Gelatin Capsule Shell Size “0” Orange Opaque cap and Orange Opaque body printed with “A” on Cap and “471” on body in black ink filled with White to Off-white powder; supplied in Bottles of 500: NDC 31722-150-05 Store gabapentin capsules at 25°C (77°F); excursions MATERIAL SAFETY DATA SHEET. Gabapentin Capsules, USP . Effective Date: 04-26-2010 . Section 1 - Chemical Product and Company . Manufacturer: Emergency Phone: InvaGen Pharmaceuticals Inc 1-631-231-3233 7, Oser Avenue . Hauppauge, NY 11788 . Common Name: Gabapentin Capsules, USP . Synonym(s): Neurontin Chemical Name: 1-(Aminomethyl · Trade name:Gabapentin · Synonym CI-945 1-(aminomethyl)-cyclohexaneacetic acid · Article number:10008346 · CAS Number: 60142-96-3 · EC number: 262-076-3 · Application of the substance / the mixture This product is for research use - Not for human or veterinary diagnostic or therapeutic use. · Details of the supplier of the safety data sheet Gabapentin Capsules, USP 1. IDENTIFICATION Manufacturer: Emergency Phone: Ascent Pharmaceuticals Inc 1-855-221-1622 400 S.Technology Dr. Central Islip, NY 11722 Common Name: Gabapentin Capsules Chemical Family: Cyclohexane-acetic acid derivative Synonym(s): Not Applicable Chemical Name: 2-[1-(amino methyl) cyclohexyl] acetic acid Therapeutic Category: Used to relieve pain, especially neuropathic pain, Anticonvulsant. Not considered hazardous when handled under normal conditions. GABAPENTIN EEC No. 262-076-3 Not available60142-96-3 Proprietary Excipients - Not available - Remainder SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product Name Page 1 / 6 Gabapentin Tablets and Capsules Revision Date 09-Mar-2017 Active Ingredient Gabapentin Material Name: Gabapentin Capsules (100 mg, 300 mg and 400 mg) 2 Year(s) Male Rat Oral, in feed 1000 mg/kg/day NOEL Malignant tumors, Pancreas Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, MATERIAL SAFETY DATA SHEET Version: 1.2 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Material Name: Gabapentin Capsules (100 mg, 300 mg and 400 mg) Trade Name: Neurontin® Chemical Family: Mixture Intended Use: Pharmaceutical product used as anticonvulsant 2. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Gabapentin Rat Subcutaneous LD50 > 4000mg/kg Material Name: Gabapentin Tablets (Neurontin) Gabapentin Eye Irritation Rabbit Non-irritating Povidone Mouse Oral LD50 > 5000 mg/kg Gabapentin Rat Oral LD50 100 g/kg Version: 2.1 52 Week(s) Rat Oral250 mg/kg/day NOAEL Liver, Kidney According to a classification scheme(2), this estimated Koc value suggests that gabapentin is expected to have high mobility in soil. Experimental pKa values for gabapentin are 3.68 (carboxylic acid) and 10.70 (primary amine)(4), indicating that this compound will primarily exist as a zwitterion in the environment. Chemical Book 7 MATERIAL SAFETY DATA SHEET _____ 15. REGULATORY INFORMATION 16. OTHER INFORMATION Data Sources: Pfizer proprietary drug development information. Safety data sheets for individual ingredients. Publicly available toxicity information. Reasons for Revision: _____ Gabapentin Material Name: Gabapentin Capsules (100 mg, 300 mg and 400 mg) Gabapentin Gabapentin Rat Subcutaneous LD50 > 4000mg/kg Eye Irritation Rabbit Non-irritating Material Name: Neurontin (gabapentin) Oral Solution Glycerin, USP Glycerin, USP Eye Irritation Rabbit Mild Mouse Oral LD50 > 5000 mg/kg Mouse Oral LD50 4090 mg/kg Gabapentin Version: 3.1 General Handling: If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid contact with eyes, skin, and clothing. Releases to the environment should be avoided. Common Name: Gabapentin Capsules Chemical Family: Cyclohexane-acetic acid derivative Synonym(s): Not Applicable Chemical Name: 2-[1-(amino methyl) cyclohexyl] acetic acid Trade Name(s): Gabapentin Capsules, USP 100 mg, 300 mg and 400 mg. Therapeutic Category: Used to relieve pain, especially neuropathic pain, Anticonvulsant. Molecular formula Discover the power of Msds Gabapentin Capsules to alleviate pain and manage epilepsy. 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