Home NDC 69367-304 Miglitol
Product NDC 69367-304
11-digit product format 693670304
Labeler code 69367
Product ID 69367-304_d28d00da-e102-098c-e053-2995a90a8121
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Miglitol
Dosage form TABLET, COATED
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application ANDA203965
Marketing category ANDA
Marketing start 2021-01-15
Substance MIGLITOL
Active strength 50 mg/1
Pharmacologic classes alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [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 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.
Additional Listing Data#
Finished product Yes
Brand name base Miglitol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIGLITOL 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0V5436JAQW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205329 Internal RxNorm lookup 205330 Internal RxNorm lookup 205331 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69367-304-01 Miglitol 100 in 1 BOTTLE TABLET, COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-304 MIGLITOL TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20211208_b8da2015-d254-2425-e053-2995a90acf0e.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 69367-304-01 69367030401 100 TABLET, COATED in 1 BOTTLE (69367-304-01) 2021-01-15 0000-00-00 No No Current