ZOLPIDEM TARTRATE

Product NDC
40032-762
11-digit product format
400320762
Labeler code
40032
Product ID
40032-762_207a5ac6-0a75-4c30-9af9-2d705101a342
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Novel Laboratories, Inc.
Application
ANDA204299
Marketing category
ANDA
Marketing start
2016-03-22
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
2 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-762-01ZOLPIDEM TARTRATE1 in 1 POUCHTABLET16
40032-762-01ZOLPIDEM TARTRATE1 in 1 BLISTER PACKTABLET16
40032-762-30ZOLPIDEM TARTRATE30 in 1 CARTONTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-762ZOLPIDEM TARTRATE TABLET [NOVEL LABORATORIES, INC.]6Legacy NDC, 3 package rows20191221_0621151f-90c7-4915-bfd8-26e8447b10bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232194zolpidem tartrate 1.75 MG Sublingual TabletPSN0621151f-90c7-4915-bfd8-26e8447b10bd6
1232202zolpidem tartrate 3.5 MG Sublingual TabletPSN0621151f-90c7-4915-bfd8-26e8447b10bd6
1232194zolpidem tartrate 1.75 MG Sublingual TabletSCD0621151f-90c7-4915-bfd8-26e8447b10bd6
1232202zolpidem tartrate 3.5 MG Sublingual TabletSCD0621151f-90c7-4915-bfd8-26e8447b10bd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-762-01400320762011 in 1 POUCHHistorical
40032-762-304003207623030 POUCH in 1 CARTON (40032-762-30) > 1 BLISTER PACK in 1 POUCH (40032-762-01) > 1 TABLET in 1 BLISTER PACK30 pouch2016-03-220000-00-00NoNoCurrent