Zolpidem Tartrate

Product NDC
55700-971
11-digit product format
557000971
Labeler code
55700
Product ID
55700-971_d84b90d7-f7c5-4b9f-9606-ab578da64c67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA213592
Marketing category
ANDA
Marketing start
2022-06-02
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-971-30EA - Each55700-971db564a1c-176e-404e-b610-efa808f5bc1112022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-971ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]2Legacy NDC20230817_c06206c8-43e5-4d73-bfce-66f35b60dd78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-971-305570009713030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-971-30) 2022-06-020000-00-00NoNoCurrent