NDC 45865-363
Orphenadrine Citrate 100 mg tablet
On the label: Medsource Pharmaceuticals. It's repackaged: Medsource Pharmaceuticals rebottles it from Sandoz Inc.'s NDC 0185-0022.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Sandoz Inc. names for other drugs.
Repackaging site
- Medsource Pharmaceuticals, Rancho Santa Margarita, CA, United States · repackages it
Recalls
- Mar 21, 2022 · Class II · Sandoz, Inc
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Lots: Lot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 Lot #: KL3199, KM0072,KS3939, Exp. 03/2023 Lot #: LA7704, LA7703,LA9243, Exp. 11/2023 - Jul 11, 2014 · Class III · Sandoz Inc
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Lots: Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Orphenadrine: every company that makes it
- Form
- tablet
- Strength
- 100 mg
- Approval
- ANDA ANDA040327
- On the market since
- Feb 15, 2000
- Package NDCs
45865-363-3045865-363-4945865-363-6045865-363-90- Official label
- DailyMed (National Library of Medicine), updated Aug 13, 2015
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?