FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
71610-915
11-digit product format
716100915
Labeler code
71610
Product ID
71610-915_3882cb55-965e-f0c7-e063-6394a90a6c46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077214
Marketing category
ANDA
Marketing start
2007-04-23
Substance
ZOLPIDEM TARTRATE
Active strength
10 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 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
71610-915-10ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET, FILM COATED101
71610-915-14ZOLPIDEM TARTRATE14 in 1 BOTTLETABLET, FILM COATED141
71610-915-15ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET, FILM COATED151
71610-915-20ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET, FILM COATED201
71610-915-21ZOLPIDEM TARTRATE21 in 1 BOTTLETABLET, FILM COATED211
71610-915-25ZOLPIDEM TARTRATE25 in 1 BOTTLETABLET, FILM COATED251
71610-915-28ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET, FILM COATED281
71610-915-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, FILM COATED301
71610-915-45ZOLPIDEM TARTRATE45 in 1 BOTTLETABLET, FILM COATED451
71610-915-53ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, FILM COATED601
71610-915-59ZOLPIDEM TARTRATE22 in 1 BOTTLETABLET, FILM COATED221
71610-915-60ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET, FILM COATED901
71610-915-62ZOLPIDEM TARTRATE11 in 1 BOTTLETABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-915-10EA - Each71610-915307d5f5a-fa43-46f1-bccb-795bcd746c6112025-08-11
71610-915-14EA - Each71610-9150762cb39-31ac-4fda-8db4-830fd6d97b0712025-08-11
71610-915-15EA - Each71610-91590cadb85-3816-4008-963e-41d82ee0369612025-08-11
71610-915-20EA - Each71610-915936121c2-5c83-4928-a1b5-1484a70922e412025-08-11
71610-915-21EA - Each71610-9155d597965-0b91-4dea-9632-bf0bff56b25b12025-08-11
71610-915-25EA - Each71610-91537d8bcad-1674-4972-a7b6-96abbedb5faf12025-08-11
71610-915-28EA - Each71610-915dc9ae2a4-1112-4159-b74f-80573cd5605612025-08-11
71610-915-30EA - Each71610-91542c62315-87e9-4362-b999-3a9b5f8ce3c212025-08-11
71610-915-45EA - Each71610-915f2673b13-da0c-47e6-a413-79372abb175b12025-08-11
71610-915-53EA - Each71610-915dd40eef9-b504-4c4c-8ea9-c23a53c022a512025-08-11
71610-915-59EA - Each71610-91591086af5-8c12-473a-b7a8-acbabc9fdc6d12025-08-11
71610-915-60EA - Each71610-915c0a9ae24-3553-410e-9fd3-4d358db1743a12025-08-11
71610-915-62EA - Each71610-915631ab95e-c368-4f44-a904-c6c5015a548112025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN3882d72d-686b-406b-e063-6294a90a0b891
854873zolpidem tartrate 10 MG Oral TabletSCD3882d72d-686b-406b-e063-6294a90a0b891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-915-107161009151010 TABLET, FILM COATED in 1 BOTTLE (71610-915-10) 2025-06-23NoNoHistorical
71610-915-147161009151414 TABLET, FILM COATED in 1 BOTTLE (71610-915-14) 2025-06-23NoNoHistorical
71610-915-157161009151515 TABLET, FILM COATED in 1 BOTTLE (71610-915-15) 2025-06-23NoNoHistorical
71610-915-207161009152020 TABLET, FILM COATED in 1 BOTTLE (71610-915-20) 2025-06-23NoNoHistorical
71610-915-217161009152121 TABLET, FILM COATED in 1 BOTTLE (71610-915-21) 2025-06-23NoNoHistorical
71610-915-257161009152525 TABLET, FILM COATED in 1 BOTTLE (71610-915-25) 2025-06-23NoNoHistorical
71610-915-287161009152828 TABLET, FILM COATED in 1 BOTTLE (71610-915-28) 2025-06-23NoNoHistorical
71610-915-307161009153030 TABLET, FILM COATED in 1 BOTTLE (71610-915-30) 2025-06-23NoNoHistorical
71610-915-457161009154545 TABLET, FILM COATED in 1 BOTTLE (71610-915-45) 2025-06-23NoNoHistorical
71610-915-537161009155360 TABLET, FILM COATED in 1 BOTTLE (71610-915-53) 2025-06-23NoNoHistorical
71610-915-597161009155922 TABLET, FILM COATED in 1 BOTTLE (71610-915-59) 2025-06-23NoNoHistorical
71610-915-607161009156090 TABLET, FILM COATED in 1 BOTTLE (71610-915-60) 2025-06-23NoNoHistorical
71610-915-627161009156211 TABLET, FILM COATED in 1 BOTTLE (71610-915-62) 2025-06-23NoNoHistorical