FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
71610-192
11-digit product format
716100192
Labeler code
71610
Product ID
71610-192_b721f5f7-f18b-4d24-a12d-afaf21d21ea3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
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 Tartrate
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
71610-192-15Zolpidem Tartrate15 in 1 BOTTLETABLET, FILM COATED152
71610-192-20Zolpidem Tartrate20 in 1 BOTTLETABLET, FILM COATED202
71610-192-25Zolpidem Tartrate25 in 1 BOTTLETABLET, FILM COATED252
71610-192-28Zolpidem Tartrate28 in 1 BOTTLETABLET, FILM COATED282
71610-192-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED302
71610-192-59Zolpidem Tartrate22 in 1 BOTTLETABLET, FILM COATED222
71610-192-60Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-192-15EA - Each71610-192e63434d6-36a9-4a31-8523-ef4a47725d1512019-01-24
71610-192-20EA - Each71610-192b2ef546f-4381-435f-b643-5360b4b2960a12019-01-24
71610-192-25EA - Each71610-192b3be91fe-3bd2-4fa9-84a3-8c303991dd4412019-01-24
71610-192-28EA - Each71610-19284f1cb0b-bac6-4778-8b2d-13abe0c746eb12019-01-24
71610-192-30EA - Each71610-1925dcb2de9-3d69-483c-a970-50d9a330f77312019-01-24
71610-192-59EA - Each71610-1922eb001b2-5e7a-42b7-9092-73abbb31b4c712019-01-24
71610-192-60EA - Each71610-192502da03e-6e99-4ad2-b532-948f06ae1bc012019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-192ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 7 package rows20190109_acfcfe91-83a0-44ab-95c0-dd98b73ac69a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNacfcfe91-83a0-44ab-95c0-dd98b73ac69a2
854873zolpidem tartrate 10 MG Oral TabletSCDacfcfe91-83a0-44ab-95c0-dd98b73ac69a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-192-157161001921515 TABLET, FILM COATED in 1 BOTTLE (71610-192-15) 2018-11-080000-00-00NoNoCurrent
71610-192-207161001922020 TABLET, FILM COATED in 1 BOTTLE (71610-192-20) 2018-11-080000-00-00NoNoCurrent
71610-192-257161001922525 TABLET, FILM COATED in 1 BOTTLE (71610-192-25) 2018-11-080000-00-00NoNoCurrent
71610-192-287161001922828 TABLET, FILM COATED in 1 BOTTLE (71610-192-28) 2018-11-080000-00-00NoNoCurrent
71610-192-307161001923030 TABLET, FILM COATED in 1 BOTTLE (71610-192-30) 2018-11-080000-00-00NoNoCurrent
71610-192-597161001925922 TABLET, FILM COATED in 1 BOTTLE (71610-192-59) 2018-11-080000-00-00NoNoCurrent
71610-192-607161001926090 TABLET, FILM COATED in 1 BOTTLE (71610-192-60) 2018-11-080000-00-00NoNoCurrent