Home NDC 68382-657 glyburide
Product NDC 68382-657
11-digit product format 683820657
Labeler code 68382
Product ID 68382-657_1ff75368-1bfd-4173-b0aa-18eca2c97a4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glyburide
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA206749
Marketing category ANDA
Marketing start 2016-06-02
Substance GLYBURIDE
Active strength 2.5 mg/1
Pharmacologic classes 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 1 .
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 A206749-001 GLYBURIDE GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 A206749-002 GLYBURIDE GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 A206749-003 GLYBURIDE GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206749-002 GLYBURIDE 2.5MG TABLET / ORAL AB1 2016-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206749-003 GLYBURIDE 5MG TABLET / ORAL AB1 2016-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206749-001 GLYBURIDE 1.25MG TABLET / ORAL AB1 2016-05-10 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base glyburide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYBURIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SX6K58TVWC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197737 Internal RxNorm lookup 310534 Internal RxNorm lookup 310537 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-657 GLYBURIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 3 Current NDC, Legacy NDC, 7 package rows 20221117_87781ea8-62ec-483c-a4dd-8c965ce59485.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 · 2 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 68382-657-01 68382065701 100 TABLET in 1 BOTTLE (68382-657-01) 100 tablet 2016-06-02 0000-00-00 No No Current 68382-657-05 68382065705 500 TABLET in 1 BOTTLE (68382-657-05) 500 tablet 2016-06-02 0000-00-00 No No Current 68382-657-06 68382065706 30 TABLET in 1 BOTTLE (68382-657-06) 30 tablet 2016-06-02 0000-00-00 No No Current 68382-657-10 68382065710 1000 TABLET in 1 BOTTLE (68382-657-10) 1000 tablet 2016-06-02 0000-00-00 No No Current 68382-657-16 68382065716 90 TABLET in 1 BOTTLE (68382-657-16) 90 tablet 2016-06-02 0000-00-00 No No Current 68382-657-30 68382065730 10 in 1 BLISTER PACK Historical 68382-657-77 68382065777 10 BLISTER PACK in 1 CARTON (68382-657-77) / 10 TABLET in 1 BLISTER PACK (68382-657-30) 10 blister pack 2016-06-02 0000-00-00 No No Current