Sumatriptan 6 mg/.5mL
Sumatriptan · INJECTION, SOLUTION · Somerset Therapeutics, LLC
Sumatriptan is a prescription medication used to treat acute migraine headaches and cluster headaches by narrowing blood vessels around the brain and reducing substances in the body that can trigger headaches, nausea, sensitivity to light, and sound. This injectable form is administered under the skin and works quickly to relieve migraine symptoms.
Key Facts
- Brand Name
- Sumatriptan
- Generic Name
- Sumatriptan
- NDC Code (Product)
70069-804- Manufacturer
- Somerset Therapeutics, LLC
- Strength
- 6 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA213998
- Marketing Start
- 10/25/2021
Recall History
GlaxoSmithKline, LLC.
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Sun Pharmaceutical Industries, Inc.
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
GlaxoSmithKline, LLC.
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Sun Pharmaceutical Industries, Inc.
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is Sumatriptan used for?
Sumatriptan is a prescription medication used to treat acute migraine headaches and cluster headaches by narrowing blood vessels around the brain and reducing substances in the body that can trigger headaches, nausea, sensitivity to light, and sound. This injectable form is administered under the skin and works quickly to relieve migraine symptoms.
Is Sumatriptan a controlled substance?
Sumatriptan is not classified as a controlled substance by the DEA.
What is the generic name for Sumatriptan?
The generic name for Sumatriptan is Sumatriptan. There are 8 other brand versions of Sumatriptan.
What is the NDC code for Sumatriptan 6 mg/.5mL?
The NDC (National Drug Code) for Sumatriptan 6 mg/.5mL is 70069-804, listed by Somerset Therapeutics, LLC.