Home NDC 63629-8448 Repaglinide
Product NDC 63629-8448
11-digit product format 636298448
Labeler code 63629
Product ID 63629-8448_2dc7db63-38df-4cf2-90a9-d08c6c23ca71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name REPAGLINIDE
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA201189
Marketing category ANDA
Marketing start 2014-01-22
Marketing end 0000-00-00
Substance REPAGLINIDE
Active strength 1 mg/1
Pharmacologic classes Glinide [EPC], Potassium Channel Antagonists [MoA]
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, 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 63629-8448-1 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 63629-8448-1 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 63629-8448-1 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 63629-8448-1 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 63629-8448-1 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 63629-8448-1 cdf11ea48f46…ba0047e9e063…
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 A201189-001 REPAGLINIDE REPAGLINIDE 0.5MG TABLET / ORAL 2013-07-17 A201189-002 REPAGLINIDE REPAGLINIDE 1MG TABLET / ORAL 2014-01-22 A201189-003 REPAGLINIDE REPAGLINIDE 2MG TABLET / ORAL 2014-01-22
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 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201189-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201189-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201189-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-07-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8448-1 63629844801 100 TABLET in 1 BOTTLE (63629-8448-1) 100 tablet 2014-01-22 0000-00-00 No No Current