Zolpidem

Product NDC
71335-2303
11-digit product format
713352303
Labeler code
71335
Product ID
71335-2303_63c2f4f7-4863-463b-be0e-5ac58f64f9c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolpidem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2303-1Zolpidem1000 in 1 BOTTLETABLET1000100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2303-1EA - Each71335-23034e1508f8-dd1d-4640-a9f6-9557bcca750e12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2303ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20231207_33094305-4bbd-4b52-9079-8853d5f83682.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN33094305-4bbd-4b52-9079-8853d5f83682100
854873zolpidem tartrate 10 MG Oral TabletSCD33094305-4bbd-4b52-9079-8853d5f83682100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2303-1713352303011000 TABLET in 1 BOTTLE (71335-2303-1) 1000 tablet2023-12-01NoNoHistorical