Home NDC 62135-732 Glipizide and metformin hcl
Product NDC 62135-732
11-digit product format 621350732
Labeler code 62135
Product ID 62135-732_459bebab-b18b-58b4-e063-6294a90ad140
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glipizide and metformin hcl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA078728
Marketing category ANDA
Marketing start 2010-06-29
Substance GLIPIZIDE; METFORMIN HYDROCHLORIDE
Active strength 2.5; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23
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 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078728-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2010-06-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078728-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB 2010-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078728-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2010-06-23 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 hcl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLIPIZIDE 2.5 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 62135-732-60 Glipizide and metformin hcl 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-732 GLIPIZIDE AND METFORMIN HCL TABLET, FILM COATED [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20241030_ac018f64-fd9d-4b3c-b0ac-ca305b8df635.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 Marketing start Sample Exclude flag Status 62135-732-60 62135073260 60 TABLET, FILM COATED in 1 BOTTLE (62135-732-60) 2023-08-15 No No Current