Home NDC 52536-063 Nateglinide
Product NDC 52536-063
11-digit product format 525360063
Labeler code 52536
Product ID 52536-063_1e45811e-8694-4456-9270-388a115dcb6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nateglinide
Dosage form TABLET
Route ORAL
Labeler Wilshire Pharmaceuticals, Inc.
Application ANDA205544
Marketing category ANDA
Marketing start 2019-04-20
Marketing end 0000-00-00
Substance NATEGLINIDE
Active strength 60 mg/1
Pharmacologic classes Glinide [EPC],Potassium Channel Antagonists [MoA]
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A205544-001 NATEGLINIDE NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 A205544-002 NATEGLINIDE NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 2026-08-18 06:07:40 2026-07 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205544-001 NATEGLINIDE 60MG TABLET / ORAL AB 2018-06-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205544-002 NATEGLINIDE 120MG TABLET / ORAL AB 2018-06-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 52536-063-10 2021-03-29 These highlights do not include all the information needed to use NATEGLINIDE TABLETS, USP safely and effectively. See full prescribing information for NATEGLINIDE TABLETS, USP. NATEGLINIDE tablets, for oral use Initial U.S. Approval: 2000 52536-063-50 2021-03-29 These highlights do not include all the information needed to use NATEGLINIDE TABLETS, USP safely and effectively. See full prescribing information for NATEGLINIDE TABLETS, USP. NATEGLINIDE tablets, for oral use Initial U.S. Approval: 2000 52536-063-10 2021-01-29 These highlights do not include all the information needed to use NATEGLINIDE TABLETS, USP safely and effectively. See full prescribing information for NATEGLINIDE TABLETS, USP. NATEGLINIDE tablets, for oral use Initial U.S. Approval: 2000 52536-063-50 2021-01-29 These highlights do not include all the information needed to use NATEGLINIDE TABLETS, USP safely and effectively. See full prescribing information for NATEGLINIDE TABLETS, USP. NATEGLINIDE tablets, for oral use Initial U.S. Approval: 2000
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.