FDA.reportPublic FDA data

Zolpidem

Product NDC
71093-156
11-digit product format
710930156
Labeler code
71093
Product ID
71093-156_69a3d187-578f-4e49-b8b3-109219a7bdf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
ACI Healthcare USA, Inc
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, 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
71093-156-04Zolpidem100 in 1 BOTTLETABLET1007
71093-156-06Zolpidem1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-156-04EA - Each71093-15627984ae4-5927-4ab3-9be3-31b89a83c71212020-05-08
71093-156-06EA - Each71093-1566c50c9f7-cca3-4858-92af-5b568f2c041112020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-156ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [ACI HEALTHCARE USA, INC]7Current NDC, Legacy NDC, 2 package rows20231217_021153ce-fe27-4ed1-8d88-b4157b0ed734.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN3aa7e88b-7929-45ac-9e81-03f4abf28e94103
854873zolpidem tartrate 10 MG Oral TabletSCD3aa7e88b-7929-45ac-9e81-03f4abf28e94103
854873zolpidem tartrate 10 MG Oral TabletPSN74c4e793-3444-4d3d-8211-26374349ab1e102
854873zolpidem tartrate 10 MG Oral TabletSCD74c4e793-3444-4d3d-8211-26374349ab1e102
854873zolpidem tartrate 10 MG Oral TabletPSN1e5b61b6-a5bd-4f09-9d34-905ce32f1899101
854873zolpidem tartrate 10 MG Oral TabletPSN23bce69d-7918-42c2-8020-e22f292ff31f101
854873zolpidem tartrate 10 MG Oral TabletSCD1e5b61b6-a5bd-4f09-9d34-905ce32f1899101
854873zolpidem tartrate 10 MG Oral TabletSCD23bce69d-7918-42c2-8020-e22f292ff31f101
854873zolpidem tartrate 10 MG Oral TabletPSN33094305-4bbd-4b52-9079-8853d5f83682100
854873zolpidem tartrate 10 MG Oral TabletSCD33094305-4bbd-4b52-9079-8853d5f83682100
854873zolpidem tartrate 10 MG Oral TabletPSNc6824c69-76bc-4ca0-a6b1-5cddc2c42fc97
854873zolpidem tartrate 10 MG Oral TabletPSN021153ce-fe27-4ed1-8d88-b4157b0ed7347
854876zolpidem tartrate 5 MG Oral TabletPSN021153ce-fe27-4ed1-8d88-b4157b0ed7347
854873zolpidem tartrate 10 MG Oral TabletSCDc6824c69-76bc-4ca0-a6b1-5cddc2c42fc97
854873zolpidem tartrate 10 MG Oral TabletSCD021153ce-fe27-4ed1-8d88-b4157b0ed7347
854876zolpidem tartrate 5 MG Oral TabletSCD021153ce-fe27-4ed1-8d88-b4157b0ed7347
854873zolpidem tartrate 10 MG Oral TabletPSN1a8f7696-0d02-dd1f-e063-6394a90a58662
854873zolpidem tartrate 10 MG Oral TabletPSN004bd09e-db2d-dca1-e063-6394a90a3f632
854876zolpidem tartrate 5 MG Oral TabletPSN1a8f7696-0d02-dd1f-e063-6394a90a58662
854873zolpidem tartrate 10 MG Oral TabletSCD004bd09e-db2d-dca1-e063-6394a90a3f632
854873zolpidem tartrate 10 MG Oral TabletSCD1a8f7696-0d02-dd1f-e063-6394a90a58662
854876zolpidem tartrate 5 MG Oral TabletSCD1a8f7696-0d02-dd1f-e063-6394a90a58662
854873zolpidem tartrate 10 MG Oral TabletPSNe2ae3dd6-1d9e-e5e4-e053-2995a90a9a6f1
854873zolpidem tartrate 10 MG Oral TabletPSNf76eb9d8-ca7d-4479-bd16-52a57f623b021
854873zolpidem tartrate 10 MG Oral TabletSCDe2ae3dd6-1d9e-e5e4-e053-2995a90a9a6f1
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
71093-156-0471093015604100 TABLET in 1 BOTTLE (71093-156-04) 100 tablet2020-09-240000-00-00NoNoCurrent
71093-156-06710930156061000 TABLET in 1 BOTTLE (71093-156-06) 1000 tablet2020-09-240000-00-00NoNoCurrent