ZOLPIDEM TARTRATE

Product NDC
72189-230
11-digit product format
721890230
Labeler code
72189
Product ID
72189-230_2c284f45-9281-161b-e063-6294a90a9a08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLPIDEM TARTRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078970
Marketing category
ANDA
Marketing start
2021-06-04
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [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 TARTRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880

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
72189-230-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-230-30EA - Each72189-230c2685eb3-8377-4eb2-9d3e-f766734292d312021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-230ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250121_c3f23bc3-595b-28e5-e053-2a95a90a9c2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNc3f23bc3-595b-28e5-e053-2a95a90a9c2c2
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDc3f23bc3-595b-28e5-e053-2a95a90a9c2c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-230-307218902303030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-230-30) 2021-06-040000-00-00NoNoCurrent