Zolpidem

Product NDC
71205-691
11-digit product format
712050691
Labeler code
71205
Product ID
71205-691_f76eb9d8-ca7d-4479-bd16-52a57f623b02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-691-30Zolpidem30 in 1 BOTTLETABLET301
71205-691-60Zolpidem60 in 1 BOTTLETABLET601
71205-691-90Zolpidem90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-691-30EA - Each71205-691ff859deb-70b9-4cee-99f2-ad2e14ee3c1812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-691ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20220904_f76eb9d8-ca7d-4479-bd16-52a57f623b02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNf76eb9d8-ca7d-4479-bd16-52a57f623b021
854873zolpidem tartrate 10 MG Oral TabletSCDf76eb9d8-ca7d-4479-bd16-52a57f623b021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-691-307120506913030 TABLET in 1 BOTTLE (71205-691-30) 30 tablet2022-08-300000-00-00NoNoCurrent
71205-691-607120506916060 TABLET in 1 BOTTLE (71205-691-60) 60 tablet2022-08-300000-00-00NoNoCurrent
71205-691-907120506919090 TABLET in 1 BOTTLE (71205-691-90) 90 tablet2022-08-300000-00-00NoNoCurrent