0115-1281 : Morphine Sulfate 80 mg Oral Capsule, Extended Release

NDC:	0115-1281
Labeler:	Impax Generics
Product Type:	Human Prescription Drug
Drug Name:	Morphine Sulfate
Dosage Form:	Oral Capsule, Extended Release
Application #:	ANDA200411
Rev. Date:	Apr 12, 2016
CSA Schedule:	CII (US) [1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	J66
Shapes:	Capsule
Colors:	Orange
Size (mm):	22
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 0115-1281-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0115‑1281‑01)
• 0115-1281-03: 1000 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0115‑1281‑03)
• 0115-1281-08: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0115‑1281‑08)

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Hypromelloses
• Ethylcelluloses
• Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
• Polyethylene Glycols
• Diethyl Phthalate
• Talc
• Starch, Corn
• Sucrose
• D&c Red No. 28
• D&c Yellow No. 10
• Fd&c Red No. 40
• Gelatin
• Titanium Dioxide
• Shellac
• Alcohol
• Isopropyl Alcohol
• Butyl Alcohol
• Propylene Glycol
• Ammonia
• Ferrosoferric Oxide
• Potassium Hydroxide
• Water

Pharmaceutical Classes:

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.

• 0115-1277 Morphine Sulfate 20 mg Oral Capsule, Extended Release by Impax Generics
• 0115-1278 Morphine Sulfate 30 mg Oral Capsule, Extended Release by Impax Generics
• 0115-1279 Morphine Sulfate 50 mg Oral Capsule, Extended Release by Impax Generics
• 0115-1280 Morphine Sulfate 60 mg Oral Capsule, Extended Release by Impax Generics
• 0115-1282 Morphine Sulfate 100 mg Oral Capsule, Extended Release by Impax Generics
• 0115-1479 Morphine Sulfate 40 mg Oral Capsule, Extended Release by Impax Generics
• 0054-0235 Ms 15 mg Oral Tablet by Roxane Laboratories, Inc
• 0054-0236 Ms 30 mg Oral Tablet by Roxane Laboratories, Inc
• 0054-0237 Morphine Sulfate 10 mg/5ml Oral Solution by Roxane Laboratories, Inc
• 0054-0238 Morphine Sulfate 20 mg/5ml Oral Solution by Roxane Laboratories, Inc
• 0054-0404 Morphine Sulfate 100 mg/5ml Oral Solution by Roxane Laboratories, Inc
• 0054-0517 Morphine Sulfate 100 mg/5ml Oral Solution by Roxane Laboratories, Inc
• 0121-0825 Morphine Sulfate 100 mg/5ml Oral Solution by Pharmaceutical Associates, Inc.
• 0121-0904 Morphine Sulfate 10 mg/5ml Oral Solution by Pharmaceutical Associates, Inc.
• 0228-3090 Morphine Sulfate 30 mg/1 Oral Capsule, Extended Release by Actavis Elizabeth LLC
• 0228-3091 Morphine Sulfate 60 mg/1 Oral Capsule, Extended Release by Actavis Elizabeth LLC
• 0228-3092 Morphine Sulfate 90 mg/1 Oral Capsule, Extended Release by Actavis Elizabeth LLC
• 0228-3093 Morphine Sulfate 120 mg/1 Oral Capsule, Extended Release by Actavis Elizabeth LLC
• 0228-3116 Morphine Sulfate 45 mg/1 Oral Capsule, Extended Release by Actavis Elizabeth LLC
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• More related products ...

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