Home NDC 0009-5014 Glyset
Product NDC 0009-5014
11-digit product format 000095014
Labeler code 0009
Product ID 0009-5014_f905a39f-4cb3-4d1e-a621-47f10f39e3ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name miglitol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pharmacia & Upjohn Company LLC
Application NDA020682
Marketing category NDA
Marketing start 1996-12-18
Marketing end 2021-07-31
Substance MIGLITOL
Active strength 100 mg/1
Pharmacologic classes alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0009-5014-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0009-5014-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0009-5014-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0009-5014-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0009-5014-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0009-5014-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0009-5014-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0009-5014-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0009-5014-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0009-5014-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0009-5014-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0009-5014-01 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 N020682-001 GLYSET MIGLITOL 25MG TABLET / ORAL RLD 1996-12-18 N020682-002 GLYSET MIGLITOL 50MG TABLET / ORAL RLD 1996-12-18 N020682-003 GLYSET MIGLITOL 100MG TABLET / ORAL RLD 1996-12-18
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 N020682-001 GLYSET 25MG TABLET / ORAL RLD 1996-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020682-002 GLYSET 50MG TABLET / ORAL RLD 1996-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020682-003 GLYSET 100MG TABLET / ORAL RLD 1996-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020682-001 GLYSET 25MG TABLET / ORAL RLD 1996-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020682-002 GLYSET 50MG TABLET / ORAL RLD 1996-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020682-003 GLYSET 100MG TABLET / ORAL RLD 1996-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020682-002 GLYSET 50MG TABLET / ORAL AB RLD 1996-12-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020682-003 GLYSET 100MG TABLET / ORAL AB RLD 1996-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020682-001 GLYSET 25MG TABLET / ORAL AB RLD, RS 1996-12-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIGLITOL ACTIVE INGREDIENT 0V5436JAQW GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 MIGLITOL ACTIVE MOIETY 0V5436JAQW GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GLYSET (MIGLITOL) TABLET, FILM COATED [PHARMACIA AND UPJOHN COMPANY] 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0009-5014-01 00009501401 100 TABLET, FILM COATED in 1 BOTTLE (0009-5014-01) 1996-12-18 0000-00-00 No No Current