Home NDC 55289-606-30 Glyburide
Product NDC 55289-606
Requested package NDC 55289-606-30
11-digit product format 552890606
Labeler code 55289
Product ID 55289-606_da322850-5a20-3c63-e053-2995a90ad78f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glyburide
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA017532
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1984-05-01
Marketing end 0000-00-00
Substance GLYBURIDE
Active strength 3 mg/1
Pharmacologic classes Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N017532-001 DIABETA GLYBURIDE 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 N017532-002 DIABETA GLYBURIDE 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 N017532-003 DIABETA GLYBURIDE 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01
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 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-002 DIABETA 2.5MG TABLET / ORAL AB2 RLD 1984-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017532-003 DIABETA 5MG TABLET / ORAL AB2 RLD, RS 1984-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017532-001 DIABETA 1.25MG TABLET / ORAL AB2 RLD 1984-05-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded glyburide ACTIVE INGREDIENT SX6K58TVWC GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 glyburide ACTIVE MOIETY SX6K58TVWC GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 calcium phosphate, dibasic, anhydrous INACTIVE INGREDIENT L11K75P92J GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 FD&C Red no. 40 INACTIVE INGREDIENT WZB9127XOA GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 sodium alginate INACTIVE INGREDIENT C269C4G2ZQ GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9 talc INACTIVE INGREDIENT 7SEV7J4R1U GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 9
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Glyburide GLYBURIDE TEVA Pharmaceuticals USA Inc 50d16f1d-c814-4411-8749-62561321ecce 2021-07-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 017532 application number: NDA017532
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-606-30 55289060630 30 TABLET in 1 BOTTLE, PLASTIC (55289-606-30) 30 tablet 2016-01-27 0000-00-00 No No Current