NDC 12634-907

promethazine hydrochloride and codeine phosphate 10 mg per 5 mL / 6.25 mg per 5 mL syrup

On the label: Apotheca, Inc.. It's repackaged from NDC 57664-185, made by Sun Pharmaceutical Industries, Inc. (promethazine hydrochloride and codeine phosphate). That product's FDA listing has since ended, so its label and factories are no longer published.

Where the pills inside were made

This label doesn't name the factory that makes the drug (it lists 1 site that repackages it and relabels it). 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 Apotheca, Inc. names for other drugs.

Product details

Generic drug
Codeine and Promethazine: every company that makes it
Form
syrup
Strength
10 mg per 5 mL / 6.25 mg per 5 mL
Approval
ANDA ANDA090180
On the market since
Mar 17, 2010
Package NDCs
12634-907-02 12634-907-04 12634-907-06 12634-907-08 12634-907-16 12634-907-28 12634-907-32
Official label
DailyMed (National Library of Medicine), updated Feb 1, 2017

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