Zolpidem Tartrate

Product NDC
60290-089
11-digit product format
602900089
Labeler code
60290
Product ID
60290-089_52b460fd-06b6-613d-e063-6294a90ac977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA220717
Marketing category
ANDA
Marketing start
2026-05-14
Substance
ZOLPIDEM TARTRATE
Active strength
7.5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolpidem Tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui2637353

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
60290-089-01Zolpidem Tartrate30 in 1 BOTTLECAPSULE302
60290-089-02Zolpidem Tartrate1000 in 1 BOTTLECAPSULE10002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637353zolpidem tartrate 7.5 MG Oral CapsulePSNb49f6c18-e155-4728-a79a-9354e8c3c8f42
2637353zolpidem tartrate 7.5 MG Oral CapsuleSCDb49f6c18-e155-4728-a79a-9354e8c3c8f42
2637353zolpidem tartrate 7.5 MG (equivalent to 6 MG zolpidem) Oral CapsuleSYb49f6c18-e155-4728-a79a-9354e8c3c8f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60290-089-016029000890130 CAPSULE in 1 BOTTLE (60290-089-01) 30 capsule2026-05-14NoNoCurrent
60290-089-02602900089021000 CAPSULE in 1 BOTTLE (60290-089-02) 1000 capsule2026-05-14NoNoCurrent