NDC 63187-632
Orphenadrine Citrate 100 mg tablet, extended release
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP 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
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels 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, extended release, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA040327
- On the market since
- Feb 15, 2000
- Package NDCs
63187-632-3063187-632-6063187-632-90- Official label
- DailyMed (National Library of Medicine), updated Nov 1, 2019
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?