Home NDC 68645-575-59 Glipizide
Product NDC 68645-575
Requested package NDC 68645-575-59
11-digit product format 686450575
Labeler code 68645
Product ID 68645-575_4c224fbc-84ca-04c5-e063-6394a90a4458
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glipizide
Dosage form TABLET
Route ORAL
Labeler Legacy Pharmaceutical Packaging, LLC
Application ANDA075795
Marketing category ANDA
Marketing start 2002-09-25
Substance GLIPIZIDE
Active strength 10 mg/1
Pharmacologic classes 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075795-001 GLIPIZIDE GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 A075795-002 GLIPIZIDE GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13
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 · 88 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 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB 2001-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB 2001-06-13 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLIPIZIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X7WDT95N5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310488 Internal RxNorm lookup 310490 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 68645-575-59 Glipizide 60 in 1 BOTTLE TABLET 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68645-575 GLIPIZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250321_116ffc6a-735c-49e0-a9d5-69b6bc3e3706.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 2 of 2 · 24 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 68645-575-59 68645057559 60 TABLET in 1 BOTTLE (68645-575-59) 60 tablet 2002-09-25 0000-00-00 No No Current