Glipizide

Product NDC
16714-896
11-digit product format
167140896
Labeler code
16714
Product ID
16714-896_26f0c341-a482-4dc1-aaef-f0a92a84937c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA203499
Marketing category
ANDA
Marketing start
2018-12-01
Substance
GLIPIZIDE
Active strength
10 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 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203499-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203499-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2018-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203499-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2018-07-161e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203499-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203499-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203499-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203499-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203499-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203499-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE10 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310489Internal RxNorm lookup
314006Internal RxNorm lookup
315107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
915636a4-092e-4e2e-9bc0-0d387d996977Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-896-01Glipizide100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
16714-896-02Glipizide500 in 1 BOTTLETABLET, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-896-01EA - Each16714-8967c438e94-b0bc-4182-8644-bc4175ff580612019-05-02
16714-896-02EA - Each16714-89671b9abef-9543-4067-9bb3-ef809681bf7812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-896GLIPIZIDE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC.]3Current NDC, Legacy NDC, 2 package rows20221130_915636a4-092e-4e2e-9bc0-0d387d996977.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEREMEDYREPACK INC.e4831ddb-9680-40cb-a060-4ba77c52d0aa2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203499
application number: ANDA203499
GlipizideGLIPIZIDEREMEDYREPACK INC.e593552f-9817-4cb5-b491-31ea57dea4b82026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203499
application number: ANDA203499
GlipizideGLIPIZIDENorthstar Rx LLC.915636a4-092e-4e2e-9bc0-0d387d9969772026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203499
application number: ANDA203499
ndc (product): 16714-896
GlipizideGLIPIZIDEA-S Medication Solutions5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c2023-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203499
application number: ANDA203499
GlipizideGLIPIZIDEA-S Medication Solutions15308fc4-11e3-4cd5-8f04-ab8e3433cc7d2023-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203499
application number: ANDA203499

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSNe593552f-9817-4cb5-b491-31ea57dea4b85
31510724 HR glipizide 10 MG Extended Release Oral TabletSCDe593552f-9817-4cb5-b491-31ea57dea4b85
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSYe593552f-9817-4cb5-b491-31ea57dea4b85
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSYe593552f-9817-4cb5-b491-31ea57dea4b85
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN915636a4-092e-4e2e-9bc0-0d387d9969774
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN915636a4-092e-4e2e-9bc0-0d387d9969774
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN915636a4-092e-4e2e-9bc0-0d387d9969774
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD915636a4-092e-4e2e-9bc0-0d387d9969774
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD915636a4-092e-4e2e-9bc0-0d387d9969774
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD915636a4-092e-4e2e-9bc0-0d387d9969774
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN15308fc4-11e3-4cd5-8f04-ab8e3433cc7d1
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD15308fc4-11e3-4cd5-8f04-ab8e3433cc7d1
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY15308fc4-11e3-4cd5-8f04-ab8e3433cc7d1
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY15308fc4-11e3-4cd5-8f04-ab8e3433cc7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-896-0116714089601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-896-01) 2018-12-010000-00-00NoNoCurrent
16714-896-0216714089602500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-896-02) 2018-12-010000-00-00NoNoCurrent