Orphenadrine Citrate 100 mg/1
Orphenadrine Citrate · TABLET, EXTENDED RELEASE · Lake Erie Medical DBA Quality Care Products LLC
Orphenadrine Citrate is a tablet, extended release containing orphenadrine citrate at 100 mg/1, taken oral. Manufactured by Lake Erie Medical DBA Quality Care Products LLC.
Key Facts
- Brand Name
- Orphenadrine Citrate
- Generic Name
- Orphenadrine Citrate
- NDC Code (Product)
49999-046- Manufacturer
- Lake Erie Medical DBA Quality Care Products LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040284
- Marketing Start
- 02/07/2011
Recall History
Sandoz, Inc
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Sandoz Inc
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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.
Aidapak Services, LLC
Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.
Premier Pharmacy Labs Inc
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is Orphenadrine Citrate used for?
Orphenadrine Citrate contains Orphenadrine Citrate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Orphenadrine Citrate a controlled substance?
Orphenadrine Citrate is not classified as a controlled substance by the DEA.
What is the generic name for Orphenadrine Citrate?
The generic name for Orphenadrine Citrate is Orphenadrine Citrate. There are 7 other brand versions of Orphenadrine Citrate.
What is the NDC code for Orphenadrine Citrate 100 mg/1?
The NDC (National Drug Code) for Orphenadrine Citrate 100 mg/1 is 49999-046, listed by Lake Erie Medical DBA Quality Care Products LLC.