Home NDC 68382-186 Glipizide and Metformin Hydrochloride
Product NDC 68382-186
11-digit product format 683820186
Labeler code 68382
Product ID 68382-186_e66df8de-b76f-4812-9d00-9448cb378858
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glipizide and Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA078905
Marketing category ANDA
Marketing start 2016-05-05
Substance GLIPIZIDE; METFORMIN HYDROCHLORIDE
Active strength 5; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 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 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078905-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2011-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078905-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2011-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078905-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2011-01-31 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Glipizide and Metformin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLIPIZIDE 5 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup X7WDT95N5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861731 Internal RxNorm lookup 861736 Internal RxNorm lookup 861740 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68382-186-01 Glipizide and Metformin Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 9 68382-186-10 Glipizide and Metformin Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9 68382-186-16 Glipizide and Metformin Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 9 68382-186-30 Glipizide and Metformin Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 9 68382-186-77 Glipizide and Metformin Hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-186 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 5 package rows 20241207_1b18b903-eb52-4d08-b4a5-f984957eb116.zip
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 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-186-01 68382018601 100 TABLET, FILM COATED in 1 BOTTLE (68382-186-01) 2016-05-05 0000-00-00 No No Current 68382-186-10 68382018610 1000 TABLET, FILM COATED in 1 BOTTLE (68382-186-10) 2016-05-05 0000-00-00 No No Current 68382-186-16 68382018616 90 TABLET, FILM COATED in 1 BOTTLE (68382-186-16) 2016-05-05 0000-00-00 No No Current 68382-186-30 68382018630 10 in 1 BLISTER PACK Historical 68382-186-77 68382018677 10 BLISTER PACK in 1 CARTON (68382-186-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-186-30) 10 blister pack 2016-05-05 0000-00-00 No No Current