Home NDC 62135-948 Repaglinide
Product NDC 62135-948
11-digit product format 621350948
Labeler code 62135
Product ID 62135-948_342983dc-ded9-2234-e063-6294a90ac97f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Repaglinide
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA078555
Marketing category ANDA
Marketing start 2014-01-22
Substance REPAGLINIDE
Active strength 2 mg/1
Pharmacologic classes Glinide [EPC], Potassium Channel Antagonists [MoA]
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 A078555-001 REPAGLINIDE REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 A078555-002 REPAGLINIDE REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 A078555-003 REPAGLINIDE REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078555-002 REPAGLINIDE 1MG TABLET / ORAL AB 2014-01-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078555-003 REPAGLINIDE 2MG TABLET / ORAL AB 2014-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078555-001 REPAGLINIDE 0.5MG TABLET / ORAL AB 2013-11-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Repaglinide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REPAGLINIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 668Z8C33LU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200256 Internal RxNorm lookup 200257 Internal RxNorm lookup 200258 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 62135-948-90 Repaglinide 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-948 REPAGLINIDE TABLET [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20250504_cb995e92-295e-4638-a064-978211f5afe1.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-948-90 62135094890 90 TABLET in 1 BOTTLE (62135-948-90) 90 tablet 2025-04-24 No No Current