Home NDC 0378-3133 Glipizide and Metformin Hydrochloride
Product NDC 0378-3133
11-digit product format 003783133
Labeler code 0378
Product ID 0378-3133_a60e62ce-b960-4bce-a67e-46f913f56247
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glipizide and metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA078083
Marketing category ANDA
Marketing start 2007-04-12
Marketing end 2019-11-30
Substance GLIPIZIDE; METFORMIN HYDROCHLORIDE
Active strength 5 mg/1; mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-3133-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0378-3133-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0378-3133-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0378-3133-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0378-3133-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0378-3133-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0378-3133-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0378-3133-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0378-3133-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0378-3133-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0378-3133-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0378-3133-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078083-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL 2007-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078083-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL 2007-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078083-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL 2007-04-12 79d66fd596c7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GLIPIZIDE ACTIVE INGREDIENT X7WDT95N5C GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 GLIPIZIDE ACTIVE MOIETY X7WDT95N5C GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 METFORMIN ACTIVE MOIETY 9100L32L2N GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6