Glipizide Extended-Release Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-01-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
monthly-update
Hydrated at
2026-06-03 17:53:46

Label at a glance#

ProductGlipizide
Active ingredientGLIPIZIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1098-3 in bottle of 30 tablets

Glipizide ER Tablets USP, 2.5 mg

Rx only

30 tablets

2.5 mg
2.5 mg

NDC 70771-1099-3 in bottle of 30 tablets

Glipizide ER Tablets USP, 5 mg

Rx only

30 tablets

5 mg
5 mg

NDC 70771-1100-3 in bottle of 30 tablets

Glipizide ER Tablets USP, 10 mg

Rx only

30 tablets

10 mg
10 mg

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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
A203499-001GLIPIZIDEGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16
A203499-002GLIPIZIDEGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16
A203499-003GLIPIZIDEGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203499-001AB
A203499-002AB
A203499-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16c2088c7a36db…
2026-10-15 13:18:302026-09A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16c2088c7a36db…
2026-10-15 13:18:302026-09A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16c2088c7a36db…
2026-09-14 22:38:342026-08A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1684e616aacf4f…
2026-09-14 22:38:342026-08A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1684e616aacf4f…
2026-08-18 06:07:402026-07A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1679d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A203499-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203499-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203499-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A203499-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203499-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203499-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A203499-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203499-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203499-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203499-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203499-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203499-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203499-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203499-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203499-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203499-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203499-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203499-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203499-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203499-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203499-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203499-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203499-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203499-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203499-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203499-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203499-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203499-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203499-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203499-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203499-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203499-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203499-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203499-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203499-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203499-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203499-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203499-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203499-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203499-001AB179d66fd596c7…

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
91352956-7b71-40ff-9a1f-b8bf4fe03763ff98778f-7c76-4f41-8c6a-d335c74b3a1f2026-01-05Exact identifier
spl id: 91352956-7b71-40ff-9a1f-b8bf4fe03763
spl set id: ff98778f-7c76-4f41-8c6a-d335c74b3a1f

Reported adverse events (FAERS/openFDA)#

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