Glipizide

Product NDC
63629-1398
11-digit product format
636291398
Labeler code
63629
Product ID
63629-1398_2f412bc4-8fc2-4d9b-80f6-89eb15ae42e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074223
Marketing category
ANDA
Marketing start
1995-02-27
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074223-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB1995-02-27
A074223-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB1995-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074223-001AB
A074223-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074223-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074223-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074223-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074223-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074223-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074223-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074223-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074223-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074223-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074223-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074223-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074223-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074223-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074223-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074223-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074223-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074223-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074223-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074223-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074223-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074223-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074223-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074223-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074223-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074223-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074223-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074223-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074223-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074223-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X7WDT95N5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310490Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
afb65cc1-a4fb-4771-b09c-dcf6e8c5786eAvailable on FDA.report

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
63629-1398-1Glipizide100 in 1 BOTTLETABLET1001016
63629-1398-2Glipizide30 in 1 BOTTLETABLET301016
63629-1398-3Glipizide60 in 1 BOTTLETABLET601016
63629-1398-4Glipizide90 in 1 BOTTLETABLET901016
63629-1398-5Glipizide20 in 1 BOTTLETABLET201016
63629-1398-6Glipizide180 in 1 BOTTLETABLET1801016
63629-1398-7Glipizide10 in 1 BOTTLETABLET101016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1398-1EA - Each63629-13987f553fd4-a89f-4aa7-a789-009d2b6cc11d12014-08-01
63629-1398-2EA - Each63629-1398b062b8d6-f05f-45fa-b962-ee84dc2e77ac12014-08-01
63629-1398-3EA - Each63629-139870240fbf-b071-430c-b8c1-6a6802fdb2b012014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1398GLIPIZIDE TABLET [BRYANT RANCH PREPACK]1016Current NDC, Legacy NDC, 7 package rows20240828_afb65cc1-a4fb-4771-b09c-dcf6e8c5786e.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc..02857195-33e9-4c1f-9e5f-7cc62f2836492026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.65ddb8b3-19d4-482f-8aec-49dc167a4c402026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEA-S Medication Solutions99af53db-e102-427a-a5a2-be1e69b3152d2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENorthwind Health Company, LLC3bb3b80a-30e8-62fe-e054-00144ff8d46c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.c829b7bf-1a12-44b2-b5ce-fd44a1f0d3332025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEProficient Rx LPd5398166-5698-4ee5-bd41-3c24e4445b532025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.5c627a52-e4ca-7103-e053-2a91aa0ae13f2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEA-S Medication Solutionsb31ab6dd-0277-43ee-a054-f20c462f0c562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEBryant Ranch Prepackafb65cc1-a4fb-4771-b09c-dcf6e8c5786e2024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 63629-1398
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.589dc76d-c347-0589-e053-2991aa0a25202024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.8c27962d-626b-30e6-e053-2a95a90a49c62024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.7c21db4d-6b9b-36c3-e053-2991aa0a0fd92024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEActavis Pharma, Inc.ad55dfd7-ffb5-478a-aa84-1009fa921e222023-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEA-S Medication Solutions0874340a-75a1-4ac9-b224-80c5c24e1b412023-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDENCS HealthCare of KY, LLC dba Vangard Labsbf5ff427-3ee4-4064-a55e-35daa2f12a062023-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLCd6c016f7-bf93-4322-a179-d4798234b3812017-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310490glipiZIDE 5 MG Oral TabletPSNafb65cc1-a4fb-4771-b09c-dcf6e8c5786e1016
310490glipizide 5 MG Oral TabletSCDafb65cc1-a4fb-4771-b09c-dcf6e8c5786e1016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1398-163629139801100 TABLET in 1 BOTTLE (63629-1398-1) 100 tablet2006-02-070000-00-00NoNoCurrent
63629-1398-26362913980230 TABLET in 1 BOTTLE (63629-1398-2) 30 tablet2004-12-200000-00-00NoNoCurrent
63629-1398-36362913980360 TABLET in 1 BOTTLE (63629-1398-3) 60 tablet2004-12-140000-00-00NoNoCurrent
63629-1398-46362913980490 TABLET in 1 BOTTLE (63629-1398-4) 90 tablet2012-08-020000-00-00NoNoCurrent
63629-1398-56362913980520 TABLET in 1 BOTTLE (63629-1398-5) 20 tablet2022-04-290000-00-00NoNoCurrent
63629-1398-663629139806180 TABLET in 1 BOTTLE (63629-1398-6) 180 tablet2015-05-150000-00-00NoNoCurrent
63629-1398-76362913980710 TABLET in 1 BOTTLE (63629-1398-7) 10 tablet2022-04-290000-00-00NoNoCurrent