Home NDC 82804-959 Glipizide
Product NDC 82804-959
11-digit product format 828040959
Labeler code 82804
Product ID 82804-959_f5d7a98c-d1d4-43b9-8d7e-830a33ae0c24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glipizide
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA074378
Marketing category ANDA
Marketing start 2025-05-01
Substance GLIPIZIDE
Active strength 5 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 43 .
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 A074378-001 GLIPIZIDE GLIPIZIDE 5MG TABLET / ORAL AB 1994-11-28 A074378-002 GLIPIZIDE GLIPIZIDE 10MG TABLET / ORAL AB 1994-11-28
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 · 86 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 2026-09-14 22:38:34 2026-08 A074378-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-11-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074378-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-11-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074378-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074378-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074378-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074378-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074378-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074378-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074378-001 GLIPIZIDE 5MG TABLET / ORAL AB 1994-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074378-002 GLIPIZIDE 10MG TABLET / ORAL AB 1994-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074378-001 GLIPIZIDE 5MG TABLET / ORAL 1994-11-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074378-002 GLIPIZIDE 10MG TABLET / ORAL 1994-11-28 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 5 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# 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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-959-00 82804095900 100 TABLET in 1 BOTTLE (82804-959-00) 100 tablet 2026-01-12 No No Current 82804-959-11 82804095911 1000 TABLET in 1 BOTTLE (82804-959-11) 1000 tablet 2026-01-12 No No Current 82804-959-30 82804095930 30 TABLET in 1 BOTTLE (82804-959-30) 30 tablet 2026-01-12 No No Current 82804-959-55 82804095955 500 TABLET in 1 BOTTLE (82804-959-55) 500 tablet 2026-01-12 No No Current 82804-959-60 82804095960 60 TABLET in 1 BOTTLE (82804-959-60) 60 tablet 2026-01-12 No No Current 82804-959-72 82804095972 120 TABLET in 1 BOTTLE (82804-959-72) 120 tablet 2026-01-12 No No Current 82804-959-90 82804095990 90 TABLET in 1 BOTTLE (82804-959-90) 90 tablet 2026-01-12 No No Current