FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
51991-982
11-digit product format
519910982
Labeler code
51991
Product ID
51991-982_bc0ba3a2-ce36-4ddf-a793-695b84f5c256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA213592
Marketing category
ANDA
Marketing start
2026-05-18
Substance
ZOLPIDEM TARTRATE
Active strength
12.5 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 TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880, 854894

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
51991-982-01Zolpidem Tartrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-982-01EA - Each51991-98203c1e67c-2809-484d-850e-e5da6d3b310312021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-982ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4Current NDC, Legacy NDC, 1 package rows20230805_cbda91f7-4411-4016-80d6-0a349931956d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSNcbda91f7-4411-4016-80d6-0a349931956d7
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNcbda91f7-4411-4016-80d6-0a349931956d7
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCDcbda91f7-4411-4016-80d6-0a349931956d7
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDcbda91f7-4411-4016-80d6-0a349931956d7
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN35f6c1ab-a61c-4625-b932-11a7483f1d841
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN35f6c1ab-a61c-4625-b932-11a7483f1d841
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD35f6c1ab-a61c-4625-b932-11a7483f1d841
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD35f6c1ab-a61c-4625-b932-11a7483f1d841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-982-0151991098201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-982-01) 2026-05-180000-00-00NoNoCurrent