Glipizide

Product NDC
55289-806
11-digit product format
552890806
Labeler code
55289
Product ID
55289-806_419b3f40-b99c-8778-e063-6294a90ae23a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
c829b7bf-1a12-44b2-b5ce-fd44a1f0d333Available 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
55289-806-93Glipizide180 in 1 BOTTLE, PLASTICTABLET18023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-806-14EA - Each55289-8067f998be7-25e3-4548-bc05-c8546f748eba12012-07-24
55289-806-30EA - Each55289-806b888086b-2f23-4b18-a847-f6c116b8459b12012-07-24
55289-806-60EA - Each55289-806c4303250-523e-4e0d-9422-cb1cab6a0a7b12012-07-24
55289-806-86EA - Each55289-806cfdb0916-07a7-4841-9d84-eec24941c65012012-07-24
55289-806-90EA - Each55289-806be01b677-6831-4ad5-bb7d-f7f6e22e99c812012-07-24
55289-806-93EA - Each55289-80657522896-0b34-4109-8455-7de3c897121c12016-04-04
55289-806-98EA - Each55289-806ed9f94e7-e799-4e0d-b74d-64599a110d0612020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGLIPIZIDE (GLIPIZIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-806GLIPIZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 1 package rows20240314_c829b7bf-1a12-44b2-b5ce-fd44a1f0d333.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
ndc (product): 55289-806
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
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 TabletPSNc829b7bf-1a12-44b2-b5ce-fd44a1f0d33323
310490glipizide 5 MG Oral TabletSCDc829b7bf-1a12-44b2-b5ce-fd44a1f0d33323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-806-145528908061414 TABLET in 1 BOTTLE, PLASTIC (55289-806-14) 14 tablet2014-09-020000-00-00NoNoCurrent
55289-806-305528908063030 TABLET in 1 BOTTLE, PLASTIC (55289-806-30) 30 tablet2014-09-020000-00-00NoNoCurrent
55289-806-605528908066060 TABLET in 1 BOTTLE, PLASTIC (55289-806-60) 60 tablet2014-09-020000-00-00NoNoCurrent
55289-806-8655289080686360 TABLET in 1 BOTTLE, PLASTIC (55289-806-86) 360 tablet2014-09-020000-00-00NoNoCurrent
55289-806-905528908069090 TABLET in 1 BOTTLE, PLASTIC (55289-806-90) 90 tablet2014-09-020000-00-00NoNoCurrent
55289-806-9355289080693180 TABLET in 1 BOTTLE, PLASTIC (55289-806-93) 180 tablet1995-02-270000-00-00NoNoCurrent
55289-806-9855289080698120 TABLET in 1 BOTTLE, PLASTIC (55289-806-98) 120 tablet2014-09-020000-00-00NoNoCurrent