Home NDC 43353-379 Glipizide
Product NDC 43353-379
11-digit product format 433530379
Labeler code 43353
Product ID 43353-379_2c861c05-b5b5-4ecf-a221-ad274df017e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glipizide
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA074226
Marketing category ANDA
Marketing start 1994-05-10
Marketing end 0000-00-00
Substance GLIPIZIDE
Active strength 5 mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074226-001 GLIPIZIDE GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 A074226-002 GLIPIZIDE GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074226-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-05-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074226-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-05-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-379 GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20171104_6ca4d8cb-65a4-4958-81f6-99d1733de391.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-379-60 43353037960 90 TABLET in 1 BOTTLE, PLASTIC (43353-379-60) 90 tablet 2008-10-14 0000-00-00 No No Current 43353-379-73 43353037973 135 TABLET in 1 BOTTLE, PLASTIC (43353-379-73) 135 tablet 2012-02-13 0000-00-00 No No Current 43353-379-80 43353037980 180 TABLET in 1 BOTTLE, PLASTIC (43353-379-80) 180 tablet 2008-10-14 0000-00-00 No No Current 43353-379-92 43353037992 270 TABLET in 1 BOTTLE, PLASTIC (43353-379-92) 270 tablet 2012-02-13 0000-00-00 No No Current 43353-379-98 43353037998 540 TABLET in 1 BOTTLE, PLASTIC (43353-379-98) 540 tablet 2012-02-13 0000-00-00 No No Current