FDA.reportPublic FDA data

Glipizide

Product NDC
82804-959
11-digit product format
828040959
Labeler code
82804
Product ID
82804-959_f5d7a98c-d1d4-43b9-8d7e-830a33ae0c24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074378
Marketing category
ANDA
Marketing start
2025-05-01
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C
Rxcui310488, 310490

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-959-00Glipizide100 in 1 BOTTLETABLET1001
82804-959-11Glipizide1000 in 1 BOTTLETABLET10001
82804-959-30Glipizide30 in 1 BOTTLETABLET301
82804-959-55Glipizide500 in 1 BOTTLETABLET5001
82804-959-60Glipizide60 in 1 BOTTLETABLET601
82804-959-72Glipizide120 in 1 BOTTLETABLET1201
82804-959-90Glipizide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-959-00EA - Each82804-95997d66583-f209-4989-93f9-9093f3f7099412026-02-05
82804-959-11EA - Each82804-9597f8ca8d3-49c6-496f-aa5c-dcab6ae1a73312026-02-05
82804-959-30EA - Each82804-95960272763-674d-4cba-835f-df6c73aa8bef12026-02-05
82804-959-55EA - Each82804-9595c347754-f1bb-4af7-9c00-571d92275ba212026-02-05
82804-959-60EA - Each82804-959d88a0402-d587-4d22-953b-6c53271121fc12026-02-05
82804-959-72EA - Each82804-959e3e22086-be80-4ee6-b398-20f8dc45b25c12026-02-05
82804-959-90EA - Each82804-95939e2abe6-681e-42f0-be34-8c0aa6d76cfd12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSNf5d7a98c-d1d4-43b9-8d7e-830a33ae0c241
310490glipiZIDE 5 MG Oral TabletPSNf5d7a98c-d1d4-43b9-8d7e-830a33ae0c241
310488glipizide 10 MG Oral TabletSCDf5d7a98c-d1d4-43b9-8d7e-830a33ae0c241
310490glipizide 5 MG Oral TabletSCDf5d7a98c-d1d4-43b9-8d7e-830a33ae0c241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-959-0082804095900100 TABLET in 1 BOTTLE (82804-959-00) 100 tablet2026-01-12NoNoCurrent
82804-959-11828040959111000 TABLET in 1 BOTTLE (82804-959-11) 1000 tablet2026-01-12NoNoCurrent
82804-959-308280409593030 TABLET in 1 BOTTLE (82804-959-30) 30 tablet2026-01-12NoNoCurrent
82804-959-5582804095955500 TABLET in 1 BOTTLE (82804-959-55) 500 tablet2026-01-12NoNoCurrent
82804-959-608280409596060 TABLET in 1 BOTTLE (82804-959-60) 60 tablet2026-01-12NoNoCurrent
82804-959-7282804095972120 TABLET in 1 BOTTLE (82804-959-72) 120 tablet2026-01-12NoNoCurrent
82804-959-908280409599090 TABLET in 1 BOTTLE (82804-959-90) 90 tablet2026-01-12NoNoCurrent