Glipizide

Product NDC
70518-1848
Requested package NDC
70518-1848-2
11-digit product format
705181848
Labeler code
70518
Product ID
70518-1848_49776c86-c1df-aa95-e063-6294a90a482f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204720
Marketing category
ANDA
Marketing start
2019-02-04
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-184870518-1848-2DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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

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
A204720-001GLIPIZIDEGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-002GLIPIZIDEGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-003GLIPIZIDEGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204720-001AB
A204720-002AB
A204720-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001AB18072bd15b7f6…

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03151cb5-d32b-4484-8f2a-8c5d24c7f6f1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1848-0Glipizide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9016
70518-1848-1Glipizide30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE3016
70518-1848-2Glipizide30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1848GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 3 package rows20250302_03151cb5-d32b-4484-8f2a-8c5d24c7f6f1.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEREMEDYREPACK INC.03151cb5-d32b-4484-8f2a-8c5d24c7f6f12026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (package): 70518-1848-2
ndc (product): 70518-1848
ndc11 (package): 70518184802
GlipizideGLIPIZIDEREMEDYREPACK INC.c2aadc88-22d2-467c-b2cb-03efb5a1f1c12026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.548c1f50-dbf0-49cc-b58b-fcc5937affa82026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.4632b4ec-d2f1-40cc-8ef4-256413d8dbec2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEA-S Medication Solutionsa34b58ac-42b2-4a19-a28b-cb3144ea55cd2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEREMEDYREPACK INC.bde478e6-e290-47e0-9241-ce88d927633e2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDERising Pharma Holdings, Inc.0ffe361a-c99b-4f68-a7e2-a67a71c0c4962026-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDENorthwind Health Company, LLCab2f4ea6-46e8-268a-e053-2995a90a39772026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDENorthwind Health Company, LLCff9b3b7a-5ab1-45ec-e053-6294a90af4262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEBryant Ranch Prepack0338aff9-29f9-405e-b516-06ef4b8638632024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEA-S Medication Solutions4982f018-c53c-48ec-a4e8-4834228bcf2c2023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN03151cb5-d32b-4484-8f2a-8c5d24c7f6f116
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD03151cb5-d32b-4484-8f2a-8c5d24c7f6f116
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY03151cb5-d32b-4484-8f2a-8c5d24c7f6f116
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY03151cb5-d32b-4484-8f2a-8c5d24c7f6f116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1848-27051818480230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-1848-2) 2022-08-310000-00-00NoNoCurrent