Home NDC 65841-834 glyburide
Product NDC 65841-834
11-digit product format 658410834
Labeler code 65841
Product ID 65841-834_0450d056-3523-44c3-a4cf-f4557e520ce5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glyburide
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA206749
Marketing category ANDA
Marketing start 2016-06-02
Substance GLYBURIDE
Active strength 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 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 65841-834 GLYBURIDE TABLET [ZYDUS LIFESCIENCES LIMITED] 3 Current NDC, Legacy NDC, 7 package rows 20221117_5d0e406f-285d-4716-8971-82f665345517.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 65841-834-01 65841083401 100 TABLET in 1 BOTTLE (65841-834-01) 100 tablet 2016-06-02 0000-00-00 No No Current 65841-834-05 65841083405 500 TABLET in 1 BOTTLE (65841-834-05) 500 tablet 2016-06-02 0000-00-00 No No Current 65841-834-06 65841083406 30 TABLET in 1 BOTTLE (65841-834-06) 30 tablet 2016-06-02 0000-00-00 No No Current 65841-834-10 65841083410 1000 TABLET in 1 BOTTLE (65841-834-10) 1000 tablet 2016-06-02 0000-00-00 No No Current 65841-834-16 65841083416 90 TABLET in 1 BOTTLE (65841-834-16) 90 tablet 2016-06-02 0000-00-00 No No Current 65841-834-30 65841083430 10 in 1 BLISTER PACK Historical 65841-834-77 65841083477 10 BLISTER PACK in 1 CARTON (65841-834-77) / 10 TABLET in 1 BLISTER PACK (65841-834-30) 10 blister pack 2016-06-02 0000-00-00 No No Current