Application 074223

Type
ANDA
Sponsor
WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDEGLIPIZIDETABLET;ORAL5MGNoNo
002GLIPIZIDEGLIPIZIDETABLET;ORAL10MGNoNo

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

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074223-001GLIPIZIDE5MGTABLET / 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…
2021-12-28 21:50 UTC2021-12A074223-001GLIPIZIDE5MGTABLET / ORALAB1995-02-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A074223-002GLIPIZIDE10MGTABLET / ORALAB1995-02-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A074223-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074223-002AB1782e0a99824c…

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
ndc (product): 68788-8138
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
ndc (product): 51655-810
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.c829b7bf-1a12-44b2-b5ce-fd44a1f0d3332025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 55289-806
GlipizideGLIPIZIDEProficient Rx LPd5398166-5698-4ee5-bd41-3c24e4445b532025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 63187-811
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.5c627a52-e4ca-7103-e053-2a91aa0ae13f2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 68071-4124
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
ndc (product): 63629-1398
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.589dc76d-c347-0589-e053-2991aa0a25202024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 68071-4085
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.8c27962d-626b-30e6-e053-2a95a90a49c62024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 68071-4939
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.7c21db4d-6b9b-36c3-e053-2991aa0a0fd92024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 68071-4643
GlipizideGLIPIZIDEActavis Pharma, Inc.ad55dfd7-ffb5-478a-aa84-1009fa921e222023-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 0591-0461
ndc (product): 0591-0460
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
ndc (product): 0615-8408
ndc (product): 0615-8407
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLCd6c016f7-bf93-4322-a179-d4798234b3812017-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074223
application number: ANDA074223
ndc (product): 43353-207

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0460GlipizideGlipizideActavis Pharma, Inc.ANDACurrent
0591-0460GlipizideGlipizideActavis Pharma, Inc.ANDACurrent
0591-0460GlipizideGlipizideActavis Pharma, Inc.ANDACurrent
0591-0461GlipizideGlipizideActavis Pharma, Inc.ANDACurrent
0591-0461GlipizideGlipizideActavis Pharma, Inc.ANDACurrent
0591-0461GlipizideGlipizideActavis Pharma, Inc.ANDACurrent
0615-8407GlipizideGlipizideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8407GlipizideGlipizideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8408GlipizideGlipizideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8408GlipizideGlipizideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-192GlipizideGlipizideBlenheim Pharmacal, Inc.ANDACurrent
10544-193GlipizideGlipizideBlenheim Pharmacal, Inc.ANDACurrent
21695-469GlipizideGlipizideRebel Distributors CorpANDACurrent
21695-470GlipizideGlipizideRebel Distributors CorpANDACurrent
43353-207GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0503GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-0503GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-0503GlipizideGlipizideA-S Medication SolutionsANDACurrent
50436-6462GlipizideGlipizideUnit Dose ServicesANDACurrent
50436-6463GlipizideGlipizideUnit Dose ServicesANDACurrent
51655-810GlipizideGlipizideNorthwind PharmaceuticalsANDACurrent
51655-810GlipizideGlipizideNorthwind Pharmaceuticals, LLCANDACurrent
51655-810GlipizideGlipizideNorthwind Pharmaceuticals, LLCANDACurrent
52959-822GlipizideGlipizideH.J. Harkins Company, Inc.ANDACurrent
53808-0369GlipizideGLIPIZIDEState of Florida DOH Central PharmacyANDACurrent
55289-806GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-806GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-806GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-806GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-806GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-806GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-806GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
63187-811GlipizideGlipizideProficient Rx LPANDACurrent
63187-811GlipizideGlipizideProficient Rx LPANDACurrent
63187-811GlipizideGlipizideProficient Rx LPANDACurrent
63629-1394GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-1394GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-1394GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-1394GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-1398GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-1398GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-1398GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-1398GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-6410GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-6410GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-8062GlipizideGlipizideBryant Ranch PrepackANDACurrent
67046-235GlipizideGlipizideContract Pharmacy Services-PAANDACurrent
67544-129GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-4085GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4085GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4085GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4085GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4085GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4124GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4124GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4124GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4643GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4643GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4939GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4939GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7250GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7250GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-8138GlipizideGlipizidePreferred Pharmaceuticals Inc..ANDACurrent
70518-0998GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0998GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1124GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1124GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70934-237GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-237GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-237GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent