FDA.reportPublic FDA data

Glipizide

Product NDC
43063-861
11-digit product format
430630861
Labeler code
43063
Product ID
43063-861_3a212166-4cbf-fa96-e063-6394a90a5cd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075795
Marketing category
ANDA
Marketing start
2002-09-25
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C
Rxcui310488

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
43063-861-14Glipizide14 in 1 BOTTLE, PLASTICTABLET1424
43063-861-30Glipizide30 in 1 BOTTLE, PLASTICTABLET3024
43063-861-60Glipizide60 in 1 BOTTLE, PLASTICTABLET6024
43063-861-90Glipizide90 in 1 BOTTLE, PLASTICTABLET9024
43063-861-93Glipizide180 in 1 BOTTLE, PLASTICTABLET18024
43063-861-98Glipizide120 in 1 BOTTLE, PLASTICTABLET12024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-861-14EA - Each43063-8611a357514-82be-4591-ae8d-cb6cd49da6a212018-07-03
43063-861-30EA - Each43063-86104bdf394-9322-4fbd-af2c-c83cc6c1560912018-07-03
43063-861-60EA - Each43063-861a02c6db9-8566-45b0-81b6-a2690f35186612018-07-03
43063-861-90EA - Each43063-861caa20d2a-acb1-45a0-8400-b9fe5ee306e312018-07-03
43063-861-93EA - Each43063-8615f698e5b-e48d-4951-9339-f06ecc89908c12019-03-12
43063-861-98EA - Each43063-86160ceec4f-9c35-414f-8843-8bd58efea2dd12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-861GLIPIZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 6 package rows20250112_1b2e5656-9da9-4fab-bf01-ed75896b836a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSN1b2e5656-9da9-4fab-bf01-ed75896b836a24
310488glipizide 10 MG Oral TabletSCD1b2e5656-9da9-4fab-bf01-ed75896b836a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-861-144306308611414 TABLET in 1 BOTTLE, PLASTIC (43063-861-14) 14 tablet2018-06-120000-00-00NoNoCurrent
43063-861-304306308613030 TABLET in 1 BOTTLE, PLASTIC (43063-861-30) 30 tablet2018-06-120000-00-00NoNoCurrent
43063-861-604306308616060 TABLET in 1 BOTTLE, PLASTIC (43063-861-60) 60 tablet2018-06-120000-00-00NoNoCurrent
43063-861-904306308619090 TABLET in 1 BOTTLE, PLASTIC (43063-861-90) 90 tablet2018-06-120000-00-00NoNoCurrent
43063-861-9343063086193180 TABLET in 1 BOTTLE, PLASTIC (43063-861-93) 180 tablet2018-06-120000-00-00NoNoCurrent
43063-861-9843063086198120 TABLET in 1 BOTTLE, PLASTIC (43063-861-98) 120 tablet2018-06-120000-00-00NoNoCurrent