Application 074550

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074550-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORAL1997-09-11
A074550-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORAL1997-09-11

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074550-001GLIPIZIDE5MGTABLET / ORAL1997-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074550-002GLIPIZIDE10MGTABLET / ORAL1997-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074550-001GLIPIZIDE5MGTABLET / ORALAB1997-09-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074550-002GLIPIZIDE10MGTABLET / ORALAB1997-09-1174a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A074550-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074550-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074550-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074550-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074550-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074550-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074550-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074550-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074550-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074550-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074550-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074550-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074550-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074550-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074550-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074550-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A074550-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074550-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A074550-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074550-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A074550-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074550-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074550-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074550-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074550-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074550-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074550-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074550-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074550-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074550-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A074550-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074550-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A074550-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074550-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074550-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074550-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074550-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074550-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074550-002AB1a67488948f0b…

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 5 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEAdvanced Rx of Tennessee, LLC213c4e61-9bb7-9d1b-e063-6394a90a73392024-09-03Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEBryant Ranch Prepackafb65cc1-a4fb-4771-b09c-dcf6e8c5786e2024-08-26Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals, Inc.3e295cbc-37c1-4e25-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.589dc76d-c347-0589-e053-2991aa0a25202024-07-18Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.8c27962d-626b-30e6-e053-2a95a90a49c62024-06-18Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.7c21db4d-6b9b-36c3-e053-2991aa0a0fd92024-06-12Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.62d569b8-bb34-0e06-e053-2a91aa0a2ae12024-06-06Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLCf620559f-985b-421f-98df-bc2ca1cb0ece2024-02-26Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEActavis Pharma, Inc.ad55dfd7-ffb5-478a-aa84-1009fa921e222023-12-31Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions0874340a-75a1-4ac9-b224-80c5c24e1b412023-12-28Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c2023-12-04Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions15308fc4-11e3-4cd5-8f04-ab8e3433cc7d2023-12-04Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions4982f018-c53c-48ec-a4e8-4834228bcf2c2023-11-24Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions08b01608-73c2-45e0-8de4-c6c4012611522023-10-23Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions695c178f-77f0-451e-b718-72b65e495b7e2023-10-18Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDETruPharma LLC95ea4c96-84b9-4515-9494-a93d26820f702023-10-11Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLC64c2a82f-014c-47d7-b303-23531e6bb7232023-04-14Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENCS HealthCare of KY, LLC dba Vangard Labsbf5ff427-3ee4-4064-a55e-35daa2f12a062023-02-27Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEProficient Rx LPf280acc1-d912-4f2e-b131-440e708c7b1f2022-07-01Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEProficient Rx LP31618a34-b87b-484c-8b65-1f77d8cd0f282022-04-01Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-729GlipizideglipizideApotheca Inc.ANDACurrent
12634-790GlipizideglipizideApotheca Inc.ANDACurrent
16729-139GlipizideglipizideAccord Healthcare Inc.ANDACurrent
16729-139GlipizideglipizideAccord Healthcare Inc.ANDACurrent
16729-139GlipizideglipizideAccord Healthcare Inc.ANDACurrent
16729-140GlipizideglipizideAccord Healthcare Inc.ANDACurrent
16729-140GlipizideglipizideAccord Healthcare Inc.ANDACurrent
16729-140GlipizideglipizideAccord Healthcare Inc.ANDACurrent
50090-2075GlipizideglipizideA-S Medication SolutionsANDACurrent
50090-2076GlipizideglipizideA-S Medication SolutionsANDACurrent
53002-1111GlipizideglipizideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1111GlipizideglipizideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4460GlipizideglipizideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4460GlipizideglipizideRPK Pharmaceuticals, Inc.ANDACurrent
53217-196GlipizideglipizideAidarex Pharmaceuticals LLCANDACurrent
53217-317GlipizideglipizideAidarex Pharmaceuticals LLCANDACurrent
53808-0625GlipizideglipizideState of Florida DOH Central PharmacyANDACurrent
53808-0678GlipizideglipizideState of Florida DOH Central PharmacyANDACurrent
61919-476GLIPIZIDEGLIPIZIDEDIRECT RXANDACurrent
61919-476GLIPIZIDEGLIPIZIDEDIRECT RXANDACurrent
63187-255GlipizideglipizideProficient Rx LPANDACurrent
63187-255GlipizideglipizideProficient Rx LPANDACurrent
63187-477GlipizideglipizideProficient Rx LPANDACurrent
63187-477GlipizideglipizideProficient Rx LPANDACurrent
64725-0139GlipizideglipizideTYA PharmaceuticalsANDACurrent
66267-100GlipizideglipizideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-100GlipizideglipizideNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1267GlipizideGlipizideRedPharm Drug, Inc.ANDACurrent
67296-1267GlipizideGlipizideRedPharm Drug, Inc.ANDACurrent
67296-1267GlipizideGlipizideRedPharm Drug, Inc.ANDACurrent
68071-1773GlipizideglipizideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3009GlipizideglipizideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3009GlipizideglipizideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6853GlipizideglipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6853GlipizideglipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6853GlipizideglipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6854GlipizideglipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6854GlipizideglipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6854GlipizideglipizidePreferred Pharmaceuticals Inc.ANDACurrent
70518-0115GlipizideglipizideREMEDYREPACK INC.ANDACurrent
70518-0115GlipizideglipizideREMEDYREPACK INC.ANDACurrent
70518-0115GlipizideglipizideREMEDYREPACK INC.ANDACurrent
70518-0574GlipizideglipizideREMEDYREPACK INC.ANDACurrent
70518-0574GlipizideglipizideREMEDYREPACK INC.ANDACurrent
71335-0036GlipizideglipizideBryant Ranch PrepackANDACurrent
71335-0036GlipizideglipizideBryant Ranch PrepackANDACurrent
71335-0036GlipizideglipizideBryant Ranch PrepackANDACurrent
71335-0039GlipizideglipizideBryant Ranch PrepackANDACurrent
71335-0039GlipizideglipizideBryant Ranch PrepackANDACurrent