Home NDC 76333-127-12 Miglitol
Product NDC 76333-127
Requested package NDC 76333-127-12
11-digit product format 763330127
Labeler code 76333
Product ID 76333-127_9590040d-c6bd-dbf7-e053-2a95a90a834c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Miglitol
Dosage form TABLET, COATED
Route ORAL
Labeler Orient Pharma Co., Ltd.
Application ANDA203965
Marketing category ANDA
Marketing start 2015-07-31
Marketing end 0000-00-00
Substance MIGLITOL
Active strength 100 mg/1
Pharmacologic classes alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A203965-001 MIGLITOL MIGLITOL 25MG TABLET / ORAL RS 2015-02-24 A203965-002 MIGLITOL MIGLITOL 50MG TABLET / ORAL 2015-02-24 A203965-003 MIGLITOL MIGLITOL 100MG TABLET / ORAL 2015-02-24
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 A203965-001 MIGLITOL 25MG TABLET / ORAL RS 2015-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203965-002 MIGLITOL 50MG TABLET / ORAL 2015-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203965-003 MIGLITOL 100MG TABLET / ORAL 2015-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203965-001 MIGLITOL 25MG TABLET / ORAL RS 2015-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203965-002 MIGLITOL 50MG TABLET / ORAL 2015-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203965-003 MIGLITOL 100MG TABLET / ORAL 2015-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203965-002 MIGLITOL 50MG TABLET / ORAL AB 2015-02-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203965-003 MIGLITOL 100MG TABLET / ORAL AB 2015-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203965-001 MIGLITOL 25MG TABLET / ORAL AB 2015-02-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76333-127-11 Miglitol 100 in 1 BOTTLE TABLET, COATED 100 7 76333-127-12 Miglitol 1000 in 1 BOTTLE TABLET, COATED 1000 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Miglitol ACTIVE INGREDIENT 0V5436JAQW MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Miglitol ACTIVE MOIETY 0V5436JAQW MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76333-127 MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] 7 Legacy NDC, 2 package rows 20191024_192e6ed7-9e8c-4772-9e3b-5912a1c63a31.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 Marketing start Marketing end Sample Exclude flag Status 76333-127-12 76333012712 1000 TABLET, COATED in 1 BOTTLE (76333-127-12) 2019-10-23 0000-00-00 No No Current