Glipizide

Product NDC
68071-4124
Requested package NDC
68071-4124-2
11-digit product format
680714124
Labeler code
68071
Product ID
68071-4124_3be17f13-1bc5-11f9-e063-6394a90aa4b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA074223
Marketing category
ANDA
Marketing start
1995-02-27
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-412468071-4124-2IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-412468071-4124-2IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-412468071-4124-2IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074223-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074223-002AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310488Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c627a52-e4ca-7103-e053-2a91aa0ae13fAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4124-22024-06-04Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-32024-06-04Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-62024-06-04Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-82024-06-04Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-92024-06-04Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-22023-01-30Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-32023-01-30Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-62023-01-30Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-82023-01-30Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-92023-01-30Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-22021-02-12Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-32021-02-12Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-62021-02-12Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-82021-02-12Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-92021-02-12Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-22021-01-29Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-32021-01-29Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-62021-01-29Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-82021-01-29Glipizide Tablets, USP for oral use Revised: June 2015 Rx only
68071-4124-92021-01-29Glipizide Tablets, USP for oral use Revised: June 2015 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4124-2Glipizide120 in 1 BOTTLETABLET1206
68071-4124-3Glipizide30 in 1 BOTTLETABLET306
68071-4124-6Glipizide60 in 1 BOTTLETABLET606
68071-4124-8Glipizide180 in 1 BOTTLETABLET1806
68071-4124-9Glipizide90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4124GLIPIZIDE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 5 package rows20240606_5c627a52-e4ca-7103-e053-2a91aa0ae13f.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
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
ndc (package): 68071-4124-2
ndc (product): 68071-4124
ndc11 (package): 68071412402
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
310488glipiZIDE 10 MG Oral TabletPSN5c627a52-e4ca-7103-e053-2a91aa0ae13f6
310488glipizide 10 MG Oral TabletSCD5c627a52-e4ca-7103-e053-2a91aa0ae13f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4124-268071412402120 TABLET in 1 BOTTLE (68071-4124-2) 120 tablet2017-10-250000-00-00NoNoCurrent