Home NDC 49884-985 Nateglinide
Product NDC 49884-985
11-digit product format 498840985
Labeler code 49884
Product ID 49884-985_20d37769-1721-4531-88cf-e29082373c71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nateglinide
Dosage form TABLET, COATED
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA077463
Marketing category ANDA
Marketing start 2009-09-08
Marketing end 2023-11-30
Substance NATEGLINIDE
Active strength 120 mg/1
Pharmacologic classes Glinide [EPC], Potassium Channel Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49884-985-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49884-985-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49884-985-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49884-985-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49884-985-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49884-985-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49884-985-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49884-985-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49884-985-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49884-985-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49884-985-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49884-985-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49884-985-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…
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 A077463-001 NATEGLINIDE NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 A077463-002 NATEGLINIDE NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09
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 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077463-001 NATEGLINIDE 60MG TABLET / ORAL AB 2009-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077463-002 NATEGLINIDE 120MG TABLET / ORAL AB 2009-09-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NATEGLINIDE ACTIVE INGREDIENT 41X3PWK4O2 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 NATEGLINIDE ACTIVE MOIETY 41X3PWK4O2 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NATEGLINIDE TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 7 NATEGLINIDE ACTIVE INGREDIENT 41X3PWK4O2 NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 NATEGLINIDE ACTIVE MOIETY 41X3PWK4O2 NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NATEGLINIDE TABLET, COATED [PAR PHARMACEUTICAL INC.] 4 NATEGLINIDE ACTIVE INGREDIENT 41X3PWK4O2 NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 NATEGLINIDE ACTIVE MOIETY 41X3PWK4O2 NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NATEGLINIDE TABLET, COATED [AMERICAN HEALTH PACKAGING] 3 NATEGLINIDE ACTIVE INGREDIENT 41X3PWK4O2 NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 NATEGLINIDE ACTIVE MOIETY 41X3PWK4O2 NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E NATEGLINIDE (NATEGLINIDE ) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 2
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 · 3 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 49884-985-01 49884098501 100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-985-01) 2009-09-08 2023-11-30 No No Current