Home NDC 0378-1110 Glipizide
Product NDC 0378-1110
11-digit product format 003781110
Labeler code 0378
Product ID 0378-1110_e7c9f6a0-504a-4f2b-afaf-2fa93b442b86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glipizide
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA074226
Marketing category ANDA
Marketing start 1994-05-10
Marketing end 2024-08-31
Substance GLIPIZIDE
Active strength 10 mg/1
Pharmacologic classes Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 33 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLIPIZIDE ACTIVE INGREDIENT X7WDT95N5C GLIPIZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 8 GLIPIZIDE ACTIVE MOIETY X7WDT95N5C GLIPIZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 8 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GLIPIZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLIPIZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GLIPIZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GLIPIZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 8 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GLIPIZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 8 GLIPIZIDE ACTIVE INGREDIENT X7WDT95N5C GLIPIZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 GLIPIZIDE ACTIVE MOIETY X7WDT95N5C GLIPIZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GLIPIZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLIPIZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GLIPIZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GLIPIZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GLIPIZIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-1110-01 00378111001 100 TABLET in 1 BOTTLE, PLASTIC (0378-1110-01) 100 tablet 1994-05-10 2024-08-31 No No Current 0378-1110-05 00378111005 500 TABLET in 1 BOTTLE, PLASTIC (0378-1110-05) 500 tablet 1994-05-10 2024-08-31 No No Current