ZOLPIDEM TARTRATE

Product NDC
43063-639
11-digit product format
430630639
Labeler code
43063
Product ID
43063-639_e5f84ba7-3fe4-5425-e053-2995a90ac47a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-639-01EA - Each43063-6398f1fecba-5386-419c-a6c4-019e8417032212016-03-04
43063-639-06EA - Each43063-6398419881f-104e-4636-a683-dab7bbf2c2ea12016-03-04
43063-639-10EA - Each43063-6390b893fb9-35ed-4e79-a58f-5c3f6c4ea11712016-03-04
43063-639-14EA - Each43063-6398e795078-c624-43f4-8a3a-c158703df8b912016-03-04
43063-639-15EA - Each43063-639d2be50b0-ac54-454f-aa3a-2d167dadb37312016-03-04
43063-639-21EA - Each43063-639bde6716a-f3e4-4b66-81fb-2f4e99eda71112016-03-04
43063-639-30EA - Each43063-6395ba4ddc0-52f8-4b5b-ad39-d316d425c7bd12016-03-04
43063-639-60EA - Each43063-639548e7092-29b2-44b6-992b-250e634f15e012016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]10
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-639ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]32Legacy NDC20240925_24722308-dbb8-3a2d-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-639-0143063063901100 TABLET in 1 BOTTLE, PLASTIC (43063-639-01) 100 tablet2015-11-130000-00-00NoNoCurrent
43063-639-06430630639066 TABLET in 1 BOTTLE, PLASTIC (43063-639-06) 6 tablet2015-11-130000-00-00NoNoCurrent
43063-639-104306306391010 TABLET in 1 BOTTLE, PLASTIC (43063-639-10) 10 tablet2015-11-130000-00-00NoNoCurrent
43063-639-144306306391414 TABLET in 1 BOTTLE, PLASTIC (43063-639-14) 14 tablet2015-11-130000-00-00NoNoCurrent
43063-639-154306306391515 TABLET in 1 BOTTLE, PLASTIC (43063-639-15) 15 tablet2015-11-130000-00-00NoNoCurrent
43063-639-214306306392121 TABLET in 1 BOTTLE, PLASTIC (43063-639-21) 21 tablet2015-11-130000-00-00NoNoCurrent
43063-639-304306306393030 TABLET in 1 BOTTLE, PLASTIC (43063-639-30) 30 tablet2015-11-130000-00-00NoNoCurrent
43063-639-604306306396060 TABLET in 1 BOTTLE, PLASTIC (43063-639-60) 60 tablet2015-11-130000-00-00NoNoCurrent