Home NDC 57664-747 Repaglinide
Product NDC 57664-747
11-digit product format 576640747
Labeler code 57664
Product ID 57664-747_ef7cf939-f51c-47f9-bf9e-a36f1b94daac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Repaglinide
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA077571
Marketing category ANDA
Marketing start 2013-07-11
Marketing end 0000-00-00
Substance REPAGLINIDE
Active strength 2 mg/1
Pharmacologic classes Glinide [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077571-002 REPAGLINIDE REPAGLINIDE 1MG TABLET / ORAL 2013-07-11 A077571-003 REPAGLINIDE REPAGLINIDE 2MG TABLET / ORAL 2013-07-11
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 3 · 82 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 A077571-002 REPAGLINIDE 1MG TABLET / ORAL 2013-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077571-003 REPAGLINIDE 2MG TABLET / ORAL 2013-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077571-002 REPAGLINIDE 1MG TABLET / ORAL 2013-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077571-003 REPAGLINIDE 2MG TABLET / ORAL 2013-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077571-002 REPAGLINIDE 1MG TABLET / ORAL 2013-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077571-003 REPAGLINIDE 2MG TABLET / ORAL 2013-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077571-002 REPAGLINIDE 1MG TABLET / ORAL 2013-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077571-003 REPAGLINIDE 2MG TABLET / ORAL 2013-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077571-002 REPAGLINIDE 1MG TABLET / ORAL AB 2013-07-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077571-003 REPAGLINIDE 2MG TABLET / ORAL AB 2013-07-11 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 57664-747-13 2020-11-23 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-18 2020-11-23 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-88 2020-11-23 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-13 2020-09-27 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-18 2020-09-27 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-88 2020-09-27 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-13 2020-09-25 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-18 2020-09-25 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-88 2020-09-25 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-13 2020-07-22 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-18 2020-07-22 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997 57664-747-88 2020-07-22 These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded REPAGLINIDE ACTIVE INGREDIENT 668Z8C33LU REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 REPAGLINIDE ACTIVE MOIETY 668Z8C33LU REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 MEGLUMINE INACTIVE INGREDIENT 6HG8UB2MUY REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 POLOXAMER 181 INACTIVE INGREDIENT 09Y8E6164A REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ REPAGLINIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 REPAGLINIDE ACTIVE INGREDIENT 668Z8C33LU REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 REPAGLINIDE ACTIVE MOIETY 668Z8C33LU REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 MEGLUMINE INACTIVE INGREDIENT 6HG8UB2MUY REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 POLOXAMER 181 INACTIVE INGREDIENT 09Y8E6164A REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ REPAGLINIDE TABLET [AMERICAN HEALTH PACKAGING] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57664-747-13 57664074713 500 TABLET in 1 BOTTLE (57664-747-13) 500 tablet 2013-07-11 0000-00-00 No No Current 57664-747-18 57664074718 1000 TABLET in 1 BOTTLE (57664-747-18) 1000 tablet 2013-07-11 0000-00-00 No No Current 57664-747-88 57664074788 100 TABLET in 1 BOTTLE (57664-747-88) 100 tablet 2013-07-11 0000-00-00 No No Current