Home NDC 16571-758 NATEGLINIDE
Product NDC 16571-758
11-digit product format 165710758
Labeler code 16571
Product ID 16571-758_9ed1dbe4-49df-4d94-9e8b-3cdc081a3dd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NATEGLINIDE
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA205544
Marketing category ANDA
Marketing start 2020-12-16
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 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.
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 16571-758-01 NATEGLINIDE 100 in 1 BOTTLE TABLET 100 3 16571-758-09 NATEGLINIDE 90 in 1 BOTTLE TABLET 90 3 16571-758-50 NATEGLINIDE 500 in 1 BOTTLE TABLET 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-758 NATEGLINIDE TABLET [RISING PHARMA HOLDINGS, INC.] 3 Current NDC, Legacy NDC, 3 package rows 20241211_b41f4180-96a7-411d-b827-5021e534f556.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 Marketing end Sample Exclude flag Status 16571-758-01 16571075801 100 TABLET in 1 BOTTLE (16571-758-01) 100 tablet 2020-12-16 0000-00-00 No No Current 16571-758-09 16571075809 90 TABLET in 1 BOTTLE (16571-758-09) 90 tablet 2020-12-16 0000-00-00 No No Current 16571-758-50 16571075850 500 TABLET in 1 BOTTLE (16571-758-50) 500 tablet 2020-12-16 0000-00-00 No No Current