ZOLPIMIST

Product NDC
69654-510
11-digit product format
696540510
Labeler code
69654
Product ID
69654-510_e2832023-12e9-154d-e053-2a95a90aa44d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
SPRAY, METERED
Route
ORAL
Labeler
Aytu BioPharma, Inc.
Application
NDA022196
Marketing category
NDA
Marketing start
2019-02-26
Marketing end
2023-05-31
Substance
ZOLPIDEM TARTRATE
Active strength
5 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69654-510-30ML - Milliliter69654-5109634444b-227d-4cf3-8b51-0d498fb55fce12020-02-13
69654-510-60ML - Milliliter69654-51082623f4f-78d1-4455-a66e-e8e54d1e3a9d12020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69654-510-30696540510301 BOTTLE, SPRAY in 1 CARTON (69654-510-30) > 30 SPRAY, METERED in 1 BOTTLE, SPRAY2019-02-260000-00-00NoNoCurrent
69654-510-60696540510601 BOTTLE, SPRAY in 1 CARTON (69654-510-60) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY2019-02-260000-00-00NoNoCurrent