FDA.reportPublic FDA data

Ambien

Product NDC
0713-5521
11-digit product format
007135521
Labeler code
0713
Product ID
0713-5521_2d9350bd-56ea-7273-e063-6394a90a0e61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA021774
Marketing category
NDA
Marketing start
2025-02-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ambien
Brand name suffix
CR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854880, 854882, 854894, 854896

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
0713-5521-01AmbienCR100 in 1 BOTTLETABLET, COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-5521-01EA - Each0713-552194f6a238-9603-476f-b0e5-885695f6a72b12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-5521AMBIEN CR (ZOLPIDEM TARTRATE) TABLET, COATED [COSETTE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250210_2d934da3-bd77-4470-e063-6294a90a64f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN41124767-8ff7-da5d-e063-6394a90a52032
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN41124767-8ff7-da5d-e063-6394a90a52032
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD41124767-8ff7-da5d-e063-6394a90a52032
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD41124767-8ff7-da5d-e063-6394a90a52032
854882AMBIEN CR 12.5 MG Extended Release Oral TabletPSN2d934da3-bd77-4470-e063-6294a90a64f51
854896AMBIEN CR 6.25 MG Extended Release Oral TabletPSN2d934da3-bd77-4470-e063-6294a90a64f51
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletPSN2d934da3-bd77-4470-e063-6294a90a64f51
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSN2d934da3-bd77-4470-e063-6294a90a64f51
854882zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien]SBD2d934da3-bd77-4470-e063-6294a90a64f51
854896zolpidem tartrate 6.25 MG Extended Release Oral Tablet [Ambien]SBD2d934da3-bd77-4470-e063-6294a90a64f51
854880zolpidem tartrate 12.5 MG Extended Release Oral TabletSCD2d934da3-bd77-4470-e063-6294a90a64f51
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCD2d934da3-bd77-4470-e063-6294a90a64f51
854882Ambien CR 12.5 MG Extended Release Oral TabletSY2d934da3-bd77-4470-e063-6294a90a64f51
854896Ambien CR 6.25 MG Extended Release Oral TabletSY2d934da3-bd77-4470-e063-6294a90a64f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0713-5521-0100713552101100 TABLET, COATED in 1 BOTTLE (0713-5521-01) 2025-02-07NoNoCurrent