Glipizide

Product NDC
71335-2520
11-digit product format
713352520
Labeler code
71335
Product ID
71335-2520_687074dd-3947-4d61-bad3-7857f2c67a53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074497
Marketing category
ANDA
Marketing start
2022-05-31
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A074497-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB1995-08-31
A074497-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB1995-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074497-001AB
A074497-002AB

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31c2088c7a36db…
2026-10-15 13:18:302026-09A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31c2088c7a36db…
2026-09-14 22:38:342026-08A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-3184e616aacf4f…
2026-09-14 22:38:342026-08A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-3184e616aacf4f…
2026-08-18 06:07:402026-07A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074497-001GLIPIZIDE5MGTABLET / ORALAB1995-08-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074497-002GLIPIZIDE10MGTABLET / ORALAB1995-08-314b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A074497-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A074497-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A074497-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A074497-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A074497-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074497-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074497-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074497-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074497-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074497-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074497-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074497-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074497-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074497-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074497-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074497-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074497-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074497-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074497-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074497-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074497-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074497-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074497-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074497-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074497-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074497-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074497-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074497-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074497-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074497-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074497-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074497-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074497-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074497-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074497-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074497-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074497-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074497-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074497-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074497-002AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
c0db4c38-6eed-49ca-84ab-7ed89e476822Available 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
71335-2520-1Glipizide100 in 1 BOTTLETABLET1001
71335-2520-2Glipizide30 in 1 BOTTLETABLET301
71335-2520-3Glipizide60 in 1 BOTTLETABLET601
71335-2520-4Glipizide90 in 1 BOTTLETABLET901
71335-2520-5Glipizide20 in 1 BOTTLETABLET201
71335-2520-6Glipizide180 in 1 BOTTLETABLET1801
71335-2520-7Glipizide10 in 1 BOTTLETABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2520GLIPIZIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 7 package rows20241105_c0db4c38-6eed-49ca-84ab-7ed89e476822.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEBryant Ranch Prepack00729e82-150a-464a-abe7-a3319721fbdb2026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDEBryant Ranch Prepacka59e2aaf-692c-4696-817b-3fed7a9dc52c2026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDEBryant Ranch Prepackc0db4c38-6eed-49ca-84ab-7ed89e4768222026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
ndc (product): 71335-2520
GlipizideGLIPIZIDEGolden State Medical Supply, Inc.d91d021f-f644-eac7-e053-2995a90a81c42026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDEANI Pharmaceuticals, Inc.252ba4e0-8dc3-43e3-be00-32570dc095bd2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.0b29837b-c39b-16d2-e063-6394a90abe612025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDEA-S Medication Solutionsde67216c-4579-434e-b388-5e9b104f127a2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDEA-S Medication Solutions8948b81f-401c-478e-bb3d-3b0368f5ed8b2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDEAdvanced Rx of Tennessee, LLC213c4e61-9bb7-9d1b-e063-6394a90a73392024-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLC64c2a82f-014c-47d7-b303-23531e6bb7232023-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074497
application number: ANDA074497

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310490glipiZIDE 5 MG Oral TabletPSNc0db4c38-6eed-49ca-84ab-7ed89e4768221
310490glipizide 5 MG Oral TabletSCDc0db4c38-6eed-49ca-84ab-7ed89e4768221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2520-171335252001100 TABLET in 1 BOTTLE (71335-2520-1) 100 tablet2025-01-30NoNoCurrent
71335-2520-27133525200230 TABLET in 1 BOTTLE (71335-2520-2) 30 tablet2025-01-17NoNoCurrent
71335-2520-37133525200360 TABLET in 1 BOTTLE (71335-2520-3) 60 tablet2025-01-28NoNoCurrent
71335-2520-47133525200490 TABLET in 1 BOTTLE (71335-2520-4) 90 tablet2024-11-21NoNoCurrent
71335-2520-57133525200520 TABLET in 1 BOTTLE (71335-2520-5) 20 tablet2026-08-21NoNoCurrent
71335-2520-671335252006180 TABLET in 1 BOTTLE (71335-2520-6) 180 tablet2026-08-21NoNoCurrent
71335-2520-77133525200710 TABLET in 1 BOTTLE (71335-2520-7) 10 tablet2026-08-21NoNoCurrent