FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
71610-151
11-digit product format
716100151
Labeler code
71610
Product ID
71610-151_4226ed40-0715-4369-87ae-4c2c190fff49
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
5 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 TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873, 854876

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
71610-151-15Zolpidem Tartrate15 in 1 BOTTLETABLET, FILM COATED151
71610-151-20Zolpidem Tartrate20 in 1 BOTTLETABLET, FILM COATED201
71610-151-28Zolpidem Tartrate28 in 1 BOTTLETABLET, FILM COATED281
71610-151-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED301
71610-151-45Zolpidem Tartrate45 in 1 BOTTLETABLET, FILM COATED451
71610-151-53Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED601
71610-151-60Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-151-15EA - Each71610-1511002f61f-0654-4e20-848c-c755bb96480412018-12-13
71610-151-20EA - Each71610-151d7151a3b-2d7e-444f-aab7-c88d2fe3266812018-12-13
71610-151-28EA - Each71610-1511409618c-2843-437a-a335-bf12d0a5a33512018-12-13
71610-151-30EA - Each71610-15130bfe532-0020-46bc-8026-51ace27f301e12018-12-13
71610-151-45EA - Each71610-151aa9dba5d-4640-48ed-9cf6-3bc36c0d795d12018-12-13
71610-151-53EA - Each71610-151c5f30b0e-632d-45cf-81cf-f9b1350074c512018-12-13
71610-151-60EA - Each71610-15100bf21ab-907a-4d8a-9380-1aa40c176b0712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-151ZOLPIDEM TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 7 package rows20180926_7abb6898-223c-487b-856c-068ac04f7a5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN7abb6898-223c-487b-856c-068ac04f7a5c1
854876zolpidem tartrate 5 MG Oral TabletPSN7abb6898-223c-487b-856c-068ac04f7a5c1
854873zolpidem tartrate 10 MG Oral TabletSCD7abb6898-223c-487b-856c-068ac04f7a5c1
854876zolpidem tartrate 5 MG Oral TabletSCD7abb6898-223c-487b-856c-068ac04f7a5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-151-157161001511515 TABLET, FILM COATED in 1 BOTTLE (71610-151-15) 2018-09-180000-00-00NoNoCurrent
71610-151-207161001512020 TABLET, FILM COATED in 1 BOTTLE (71610-151-20) 2018-09-180000-00-00NoNoCurrent
71610-151-287161001512828 TABLET, FILM COATED in 1 BOTTLE (71610-151-28) 2018-09-180000-00-00NoNoCurrent
71610-151-307161001513030 TABLET, FILM COATED in 1 BOTTLE (71610-151-30) 2018-09-180000-00-00NoNoCurrent
71610-151-457161001514545 TABLET, FILM COATED in 1 BOTTLE (71610-151-45) 2018-09-180000-00-00NoNoCurrent
71610-151-537161001515360 TABLET, FILM COATED in 1 BOTTLE (71610-151-53) 2018-09-180000-00-00NoNoCurrent
71610-151-607161001516090 TABLET, FILM COATED in 1 BOTTLE (71610-151-60) 2018-09-180000-00-00NoNoCurrent