Glucotrol

Product NDC
0049-0178
11-digit product format
000490178
Labeler code
0049
Product ID
0049-0178_ce46d6b5-eab4-4630-8480-f13885be938e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Roerig
Application
NDA020329
Marketing category
NDA
Marketing start
2013-05-09
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0049-0178DDiscontinued by firm2026-08-11
excluded packagepackage0049-01780049-0178-07DDiscontinued by firm2026-08-11
excluded packagepackage0049-01780049-0178-08DDiscontinued by firm2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020329-001GLUCOTROL XLGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26
N020329-002GLUCOTROL XLGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26
N020329-003GLUCOTROL XLGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020329-001AB
N020329-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALRLD1999-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALRLD1994-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-002GLUCOTROL XL10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS1994-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-003GLUCOTROL XL2.5MGTABLET, EXTENDED RELEASE / ORALABRLD1999-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020329-001GLUCOTROL XL5MGTABLET, EXTENDED RELEASE / ORALABRLD1994-04-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020329-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020329-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020329-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020329-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020329-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020329-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020329-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020329-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020329-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020329-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020329-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020329-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020329-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020329-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020329-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020329-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020329-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020329-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020329-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020329-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020329-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020329-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020329-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020329-002AB15d02ea3f76ae…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020329-001RE444592019-03-26U-14312013-09-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020329-002RE444592019-03-26U-14312013-09-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020329-003RE444592019-03-26U-14312013-09-2074a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020329-001RE444592019-03-26U-14312013-09-203f01610625f2…
2019-12-14 00:12 UTC2019-12N020329-002RE444592019-03-26U-14312013-09-203f01610625f2…
2019-12-14 00:12 UTC2019-12N020329-003RE444592019-03-26U-14312013-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09N020329-001RE444592019-03-26U-14312013-09-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N020329-002RE444592019-03-26U-14312013-09-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N020329-003RE444592019-03-26U-14312013-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N020329-001RE444592019-03-26U-14312013-09-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N020329-002RE444592019-03-26U-14312013-09-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N020329-003RE444592019-03-26U-14312013-09-20ea99ee380514…

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
0049-0178-07GlucotrolXL100 in 1 BOTTLETABLET, EXTENDED RELEASE10027
0049-0178-08GlucotrolXL500 in 1 BOTTLETABLET, EXTENDED RELEASE50027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0178-07EA - Each0049-0178f059f781-d4f9-4f88-a974-87015b114c2012013-06-04
0049-0178-08EA - Each0049-0178d35865ad-655c-401e-b708-7768141b4fc712013-06-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0178GLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]27Current NDC, Legacy NDC, 2 package rows20250406_eed99b60-d043-4249-9b2a-f05e46fb588d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glucotrol XLGLIPIZIDERoerigeed99b60-d043-4249-9b2a-f05e46fb588d2026-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020329
application number: NDA020329
ndc (product): 0049-0178

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
865568Glucotrol XL 10 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
865571Glucotrol XL 2.5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
865573Glucotrol XL 5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
86556824 HR glipizide 10 MG Extended Release Oral Tablet [Glucotrol]SBDeed99b60-d043-4249-9b2a-f05e46fb588d27
86557124 HR glipizide 2.5 MG Extended Release Oral Tablet [Glucotrol]SBDeed99b60-d043-4249-9b2a-f05e46fb588d27
86557324 HR glipizide 5 MG Extended Release Oral Tablet [Glucotrol]SBDeed99b60-d043-4249-9b2a-f05e46fb588d27
31510724 HR glipizide 10 MG Extended Release Oral TabletSCDeed99b60-d043-4249-9b2a-f05e46fb588d27
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCDeed99b60-d043-4249-9b2a-f05e46fb588d27
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDeed99b60-d043-4249-9b2a-f05e46fb588d27
86556824 HR Glucotrol XL 10 MG Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
86557124 HR Glucotrol XL 2.5 MG Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
86557324 HR Glucotrol XL 5 MG Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
865568Glucotrol XL 10 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
865571Glucotrol XL 2.5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
865573Glucotrol XL 5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0049-0178-0700049017807100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-07) 2013-05-090000-00-00NoNoCurrent
0049-0178-0800049017808500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-08) 2013-05-090000-00-00NoNoCurrent