Zaleplon

Product NDC
42043-210
11-digit product format
420430210
Labeler code
42043
Product ID
42043-210_3d5ebb15-7a9d-47e1-b0a7-f6d1fee80d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
OrchidPharma Inc
Application
ANDA090374
Marketing category
ANDA
Marketing start
2018-06-20
Marketing end
0000-00-00
Substance
ZALEPLON
Active strength
5 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42043-210-012024-03-01C16284748780-10191ceaa-63d6-198a-e063-dbdaa90aec3e47303145-6788-46bd-b9cc-37b59b145cea
42043-210-012023-07-28C16284748780-10191ceaa-63d6-198a-e063-dbdaa90aec3e47303145-6788-46bd-b9cc-37b59b145cea

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42043-210-01EA - Each42043-210f582bfbf-0d8b-4ba2-b306-3b79c593607412019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42043-210-0142043021001100 CAPSULE in 1 BOTTLE (42043-210-01) 100 capsule2018-06-200000-00-00NoNoCurrent