Home NDC 68382-721 Nateglinide
Product NDC 68382-721
11-digit product format 683820721
Labeler code 68382
Product ID 68382-721_061a2260-2804-4753-b443-17943eca74dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nateglinide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA205248
Marketing category ANDA
Marketing start 2016-10-27
Substance NATEGLINIDE
Active strength 60 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 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 A205248-001 NATEGLINIDE NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 A205248-002 NATEGLINIDE NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06
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 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205248-001 NATEGLINIDE 60MG TABLET / ORAL AB 2016-07-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205248-002 NATEGLINIDE 120MG TABLET / ORAL AB RS 2016-07-06 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nateglinide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NATEGLINIDE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 41X3PWK4O2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311919 Internal RxNorm lookup 314142 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 68382-721-01 Nateglinide 100 in 1 BOTTLE TABLET, FILM COATED 100 7 68382-721-05 Nateglinide 500 in 1 BOTTLE TABLET, FILM COATED 500 7 68382-721-06 Nateglinide 30 in 1 BOTTLE TABLET, FILM COATED 30 7 68382-721-10 Nateglinide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 68382-721-16 Nateglinide 90 in 1 BOTTLE TABLET, FILM COATED 90 7 68382-721-77 Nateglinide 10 in 1 CARTON TABLET, FILM COATED 10 7 68382-721-77 Nateglinide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-721 NATEGLINIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 7 Current NDC, Legacy NDC, 7 package rows 20231110_88698921-cd8f-4d41-96e6-ff671913c5c3.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-721-01 68382072101 100 TABLET, FILM COATED in 1 BOTTLE (68382-721-01) 2016-10-27 0000-00-00 No No Current 68382-721-05 68382072105 500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05) 2016-10-27 0000-00-00 No No Current 68382-721-06 68382072106 30 TABLET, FILM COATED in 1 BOTTLE (68382-721-06) 2016-10-27 0000-00-00 No No Current 68382-721-10 68382072110 1000 TABLET, FILM COATED in 1 BOTTLE (68382-721-10) 2016-10-27 0000-00-00 No No Current 68382-721-16 68382072116 90 TABLET, FILM COATED in 1 BOTTLE (68382-721-16) 2016-10-27 0000-00-00 No No Current 68382-721-77 68382072177 10 BLISTER PACK in 1 CARTON (68382-721-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2016-10-27 0000-00-00 No No Current