Home NDC 68071-4142 Glyburide
Product NDC 68071-4142
11-digit product format 680714142
Labeler code 68071
Product ID 68071-4142_c21527be-e32c-4f70-e053-2995a90a8630
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glyburide
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmceuticals,Inc.
Application ANDA206079
Marketing category ANDA
Marketing start 2016-06-01
Marketing end 0000-00-00
Substance GLYBURIDE
Active strength 3 mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A206079-001 GLYBURIDE GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 A206079-002 GLYBURIDE GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 A206079-003 GLYBURIDE GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30
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 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206079-002 GLYBURIDE 2.5MG TABLET / ORAL AB2 2015-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206079-003 GLYBURIDE 5MG TABLET / ORAL AB2 2015-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206079-001 GLYBURIDE 1.25MG TABLET / ORAL AB2 2015-09-30 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68071-4142-3 2023-01-30 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-6 2023-01-30 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-9 2023-01-30 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-3 2021-05-11 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-6 2021-05-11 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-9 2021-05-11 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-3 2021-01-29 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-6 2021-01-29 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only 68071-4142-9 2021-01-29 Glyburide Tablets, USP 1.25 mg, 2.5 mg and 5 mg Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4142-3 Glyburide 30 in 1 BOTTLE TABLET 30 2 68071-4142-6 Glyburide 60 in 1 BOTTLE TABLET 60 2 68071-4142-9 Glyburide 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4142 GLYBURIDE TABLET [NUCARE PHARMCEUTICALS,INC.] 2 Legacy NDC, 3 package rows 20210512_5cdfba1e-7179-a2ee-e053-2991aa0adce9.zip
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 68071-4142-3 68071414203 30 TABLET in 1 BOTTLE (68071-4142-3) 30 tablet 2017-10-31 0000-00-00 No No Current 68071-4142-6 68071414206 60 TABLET in 1 BOTTLE (68071-4142-6) 60 tablet 2017-10-31 0000-00-00 No No Current 68071-4142-9 68071414209 90 TABLET in 1 BOTTLE (68071-4142-9) 90 tablet 2017-10-31 0000-00-00 No No Current