NDC 57664-516 - Zolpidem Tartrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57664-516
Package NDCs from labels
57664-516-88, 57664-516-13, 57664-516-18
Manufacturer
Caraco Pharmaceutical Laboratories, Ltd.
Effective date
2008-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolpidem Tartrate - Caraco Pharmaceutical Laboratories, Ltd.Caraco Pharmaceutical Laboratories, Ltd.2008-09-18HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-516-13EA - Each57664-516d5c3434a-423f-445f-b166-0e67f31e1dcc12013-02-13
57664-516-18EA - Each57664-5164eff73bb-b292-4635-9be8-35282ad6be5212013-02-13
57664-516-88EA - Each57664-516b75b1868-71ef-44cc-9018-4844065a2a0412013-02-13

DailyMed Socrata Ingredients#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4219CF23-5CD1-F8D8-8F59-5143827EFB8A208db529-ae52-462d-8fd2-775b11ce63502008-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 4219CF23-5CD1-F8D8-8F59-5143827EFB8A
spl set id: 208db529-ae52-462d-8fd2-775b11ce6350

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.