FDA.reportPublic FDA data

Zolpidem

Product NDC
71610-847
11-digit product format
716100847
Labeler code
71610
Product ID
71610-847_23437493-e8b9-2892-e063-6394a90af267
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
2007-04-23
Substance
ZOLPIDEM TARTRATE
Active strength
5 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
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
71610-847-10Zolpidem10 in 1 BOTTLETABLET103
71610-847-14Zolpidem14 in 1 BOTTLETABLET143
71610-847-15Zolpidem15 in 1 BOTTLETABLET153
71610-847-20Zolpidem20 in 1 BOTTLETABLET203
71610-847-21Zolpidem21 in 1 BOTTLETABLET213
71610-847-28Zolpidem28 in 1 BOTTLETABLET283
71610-847-30Zolpidem30 in 1 BOTTLETABLET303
71610-847-45Zolpidem45 in 1 BOTTLETABLET453
71610-847-53Zolpidem60 in 1 BOTTLETABLET603
71610-847-60Zolpidem90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-847-10EA - Each71610-8475f1551a4-2b63-46b5-aeb7-3cab45d6c93712024-10-04
71610-847-14EA - Each71610-8476835985b-6fdc-4bcc-8329-d8bb2b9d9cf512024-12-10
71610-847-15EA - Each71610-847e9f59962-940d-4dbc-9058-addae2afa4db12024-09-09
71610-847-20EA - Each71610-847ab6a5206-4b58-47fe-ba2a-e995154aa49812024-09-09
71610-847-21EA - Each71610-847c549f9c4-7cb9-4ee1-9593-808b253fb18412024-09-09
71610-847-28EA - Each71610-84719d7ba1f-fd24-4138-a822-844c26833d0612024-09-09
71610-847-30EA - Each71610-8476e33cb4c-6723-4dfe-932c-5129f88b80ea12024-09-09
71610-847-45EA - Each71610-847e859cf3d-b4cc-4ad2-819e-d1c52d64f55712024-09-09
71610-847-53EA - Each71610-84797ff76c8-728e-4264-95c1-d51f6a27d0ff12024-09-09
71610-847-60EA - Each71610-84799e99588-da7d-40c2-b802-952785ef749612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-847ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]3Current NDC, 10 package rows20241001_1e13ad50-f846-813a-e063-6294a90a5878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN1e13ad50-f846-813a-e063-6294a90a58783
854876zolpidem tartrate 5 MG Oral TabletSCD1e13ad50-f846-813a-e063-6294a90a58783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-847-107161008471010 TABLET in 1 BOTTLE (71610-847-10) 10 tablet2024-08-21NoNoHistorical
71610-847-147161008471414 TABLET in 1 BOTTLE (71610-847-14) 14 tablet2024-09-27NoNoHistorical
71610-847-157161008471515 TABLET in 1 BOTTLE (71610-847-15) 15 tablet2024-07-24NoNoHistorical
71610-847-207161008472020 TABLET in 1 BOTTLE (71610-847-20) 20 tablet2024-07-24NoNoHistorical
71610-847-217161008472121 TABLET in 1 BOTTLE (71610-847-21) 21 tablet2024-07-24NoNoHistorical
71610-847-287161008472828 TABLET in 1 BOTTLE (71610-847-28) 28 tablet2024-07-24NoNoHistorical
71610-847-307161008473030 TABLET in 1 BOTTLE (71610-847-30) 30 tablet2024-07-24NoNoHistorical
71610-847-457161008474545 TABLET in 1 BOTTLE (71610-847-45) 45 tablet2024-07-24NoNoHistorical
71610-847-537161008475360 TABLET in 1 BOTTLE (71610-847-53) 60 tablet2024-07-24NoNoHistorical
71610-847-607161008476090 TABLET in 1 BOTTLE (71610-847-60) 90 tablet2024-07-24NoNoHistorical