Home NDC 64380-168 Nateglinide
Product NDC 64380-168
11-digit product format 643800168
Labeler code 64380
Product ID 64380-168_774c246f-3d18-40d4-882f-4786d9382883
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nateglinide
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA077463
Marketing category ANDA
Marketing start 2022-05-09
Substance NATEGLINIDE
Active strength 120 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Nateglinide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NATEGLINIDE 120 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 64380-168-01 Nateglinide 100 in 1 BOTTLE, PLASTIC TABLET 100 4 64380-168-02 Nateglinide 90 in 1 BOTTLE, PLASTIC TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-168 NATEGLINIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] 4 Current NDC, Legacy NDC, 2 package rows 20250226_0ccf9b07-3c21-482d-abeb-a06ceb482c7b.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 · 3 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 64380-168-01 64380016801 100 TABLET in 1 BOTTLE, PLASTIC (64380-168-01) 100 tablet 2022-05-09 0000-00-00 No No Current 64380-168-02 64380016802 90 TABLET in 1 BOTTLE, PLASTIC (64380-168-02) 90 tablet 2022-09-07 0000-00-00 No No Current