FDA.reportPublic FDA data

Glipizide

Product NDC
64980-280
11-digit product format
649800280
Labeler code
64980
Product ID
64980-280_efa05b41-c609-4076-adf4-75071cd5f5f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA204720
Marketing category
ANDA
Marketing start
2017-04-24
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
Rxcui310489, 314006, 315107

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-280-01Glipizide100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1008
64980-280-05Glipizide500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5008
64980-280-10Glipizide1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-280-01EA - Each64980-28060359123-dffc-4378-a6f4-862377c6015312017-06-15
64980-280-05EA - Each64980-280cf7d9af4-5c8b-4926-898c-88b81061d62d12017-06-15
64980-280-10EA - Each64980-2804c8d5192-aff9-44ea-b9bc-49ae5b024f9c12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-280GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 3 package rows20250502_0ffe361a-c99b-4f68-a7e2-a67a71c0c496.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNc2aadc88-22d2-467c-b2cb-03efb5a1f1c121
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDc2aadc88-22d2-467c-b2cb-03efb5a1f1c121
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYc2aadc88-22d2-467c-b2cb-03efb5a1f1c121
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYc2aadc88-22d2-467c-b2cb-03efb5a1f1c121
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN0338aff9-29f9-405e-b516-06ef4b8638638
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN0338aff9-29f9-405e-b516-06ef4b8638638
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN0338aff9-29f9-405e-b516-06ef4b8638638
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD0338aff9-29f9-405e-b516-06ef4b8638638
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD0338aff9-29f9-405e-b516-06ef4b8638638
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD0338aff9-29f9-405e-b516-06ef4b8638638
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY0338aff9-29f9-405e-b516-06ef4b8638638
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY0338aff9-29f9-405e-b516-06ef4b8638638
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY0338aff9-29f9-405e-b516-06ef4b8638638
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY0338aff9-29f9-405e-b516-06ef4b8638638
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY0338aff9-29f9-405e-b516-06ef4b8638638
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY0ffe361a-c99b-4f68-a7e2-a67a71c0c4968
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY0338aff9-29f9-405e-b516-06ef4b8638638
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNa34b58ac-42b2-4a19-a28b-cb3144ea55cd7
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDa34b58ac-42b2-4a19-a28b-cb3144ea55cd7
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYa34b58ac-42b2-4a19-a28b-cb3144ea55cd7
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYa34b58ac-42b2-4a19-a28b-cb3144ea55cd7
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNab2f4ea6-46e8-268a-e053-2995a90a39775
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDab2f4ea6-46e8-268a-e053-2995a90a39775
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYab2f4ea6-46e8-268a-e053-2995a90a39775
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYab2f4ea6-46e8-268a-e053-2995a90a39775
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY7f7ff609-d1a9-69d0-e053-2a91aa0a681b3
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN9079bc7f-6f62-db80-e053-2995a90a3ada1
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN26a65c79-3bc5-a424-e063-6394a90a848e1
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD26a65c79-3bc5-a424-e063-6394a90a848e1
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD9079bc7f-6f62-db80-e053-2995a90a3ada1
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY9079bc7f-6f62-db80-e053-2995a90a3ada1
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY26a65c79-3bc5-a424-e063-6394a90a848e1
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY9079bc7f-6f62-db80-e053-2995a90a3ada1
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY26a65c79-3bc5-a424-e063-6394a90a848e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-280-0164980028001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-280-01) 2017-04-240000-00-00NoNoCurrent
64980-280-0564980028005500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-280-05) 2017-04-240000-00-00NoNoCurrent
64980-280-10649800280101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-280-10) 2017-04-240000-00-00NoNoCurrent