Glipizide

Product NDC
57664-399
11-digit product format
576640399
Labeler code
57664
Product ID
57664-399_caa37c20-2890-4349-be9d-5702a4470ea1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077820
Marketing category
ANDA
Marketing start
2009-07-31
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-399DDiscontinued by firm2026-08-17
excluded packagepackage57664-39957664-399-13DDiscontinued by firm2026-08-17
excluded packagepackage57664-39957664-399-18DDiscontinued by firm2026-08-17
excluded packagepackage57664-39957664-399-88DDiscontinued by firm2026-08-17

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-399-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-399-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-399-88d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-399-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-399-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-399-88f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-399-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-399-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-399-882ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-399-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-399-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-399-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-399-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-399-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-399-88cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-399-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-399-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-399-88cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-399-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-399-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-399-88302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-399-18ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-399-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-399-88ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-399-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-399-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-399-880efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-399-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-399-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-399-88ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-399-18367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-399-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-399-88367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-399-18557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-399-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-399-88557ba5c1ecfa…9c80585c8c6e…

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
A077820-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORAL2006-07-11
A077820-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORAL2006-07-11

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077820-001GLIPIZIDE5MGTABLET / ORAL2006-07-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077820-002GLIPIZIDE10MGTABLET / ORAL2006-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077820-001GLIPIZIDE5MGTABLET / ORALAB2006-07-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077820-002GLIPIZIDE10MGTABLET / ORALAB2006-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077820-001GLIPIZIDE5MGTABLET / ORALAB2006-07-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077820-002GLIPIZIDE10MGTABLET / ORALAB2006-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077820-001GLIPIZIDE5MGTABLET / ORALAB2006-07-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077820-002GLIPIZIDE10MGTABLET / ORALAB2006-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077820-001GLIPIZIDE5MGTABLET / ORALAB2006-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077820-002GLIPIZIDE10MGTABLET / ORALAB2006-07-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077820-001GLIPIZIDE5MGTABLET / ORALAB2006-07-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077820-002GLIPIZIDE10MGTABLET / ORALAB2006-07-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077820-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077820-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077820-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077820-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077820-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077820-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077820-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077820-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077820-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077820-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077820-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077820-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077820-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077820-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077820-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077820-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077820-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077820-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077820-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077820-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077820-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077820-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077820-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077820-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077820-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077820-002AB1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077820-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077820-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077820-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077820-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077820-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077820-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077820-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077820-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077820-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A077820-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077820-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A077820-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077820-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077820-002AB13a93d1ddd44b…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-399-13EA - Each57664-3993637411b-9e24-4668-9a4b-86fd3e7d9e8212013-02-13
57664-399-18EA - Each57664-3993f8887c0-34a9-4f37-8f11-45aba0120f2a12013-02-13
57664-399-88EA - Each57664-3994aee6073-1436-47d3-8e0f-39fb8c82601612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TGLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGLIPIZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6