FDA.reportPublic FDA data

Zolpidem

Product NDC
71610-670
11-digit product format
716100670
Labeler code
71610
Product ID
71610-670_3613ad67-3a05-4718-8c94-ef4c72a58f12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854876

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
71610-670-30Zolpidem30 in 1 BOTTLETABLET302
71610-670-53Zolpidem60 in 1 BOTTLETABLET602
71610-670-60Zolpidem90 in 1 BOTTLETABLET902
71610-670-70Zolpidem120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-670-30EA - Each71610-67078f8aa78-3a94-4ca1-a200-de4590a4e21012022-12-07
71610-670-53EA - Each71610-670368fc416-751d-4deb-b193-35c1fdba3af012022-12-07
71610-670-60EA - Each71610-67048cb62e6-5aef-4a3a-abcd-9a0e516caef212022-12-07
71610-670-70EA - Each71610-670d84c95ff-5e6f-4c65-88cd-0f22f708a23912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-670ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20221027_8581cfad-525b-4b16-b116-a5138d9fda52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN8581cfad-525b-4b16-b116-a5138d9fda522
854876zolpidem tartrate 5 MG Oral TabletSCD8581cfad-525b-4b16-b116-a5138d9fda522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-670-307161006703030 TABLET in 1 BOTTLE (71610-670-30) 30 tablet2022-10-180000-00-00NoNoCurrent
71610-670-537161006705360 TABLET in 1 BOTTLE (71610-670-53) 60 tablet2022-10-180000-00-00NoNoCurrent
71610-670-607161006706090 TABLET in 1 BOTTLE (71610-670-60) 90 tablet2022-10-180000-00-00NoNoCurrent
71610-670-7071610067070120 TABLET in 1 BOTTLE (71610-670-70) 120 tablet2022-10-180000-00-00NoNoCurrent