Home NDC 70771-1016 Nateglinide
Product NDC 70771-1016
11-digit product format 707711016
Labeler code 70771
Product ID 70771-1016_58be95eb-5701-463e-b80c-eb9b6c2a789d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nateglinide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA205248
Marketing category ANDA
Marketing start 2016-10-27
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 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 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 70771-1016-0 Nateglinide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9 70771-1016-1 Nateglinide 100 in 1 BOTTLE TABLET, FILM COATED 100 9 70771-1016-2 Nateglinide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 9 70771-1016-3 Nateglinide 30 in 1 BOTTLE TABLET, FILM COATED 30 9 70771-1016-4 Nateglinide 10 in 1 CARTON TABLET, FILM COATED 10 9 70771-1016-5 Nateglinide 500 in 1 BOTTLE TABLET, FILM COATED 500 9 70771-1016-9 Nateglinide 90 in 1 BOTTLE TABLET, FILM COATED 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1016 NATEGLINIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 9 Current NDC, Legacy NDC, 7 package rows 20241206_a82817dd-f8c4-4172-ba86-63c2beef456a.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 70771-1016-0 70771101600 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1016-0) 2016-10-27 0000-00-00 No No Current 70771-1016-1 70771101601 100 TABLET, FILM COATED in 1 BOTTLE (70771-1016-1) 2016-10-27 0000-00-00 No No Current 70771-1016-2 70771101602 10 in 1 BLISTER PACK Historical 70771-1016-3 70771101603 30 TABLET, FILM COATED in 1 BOTTLE (70771-1016-3) 2016-10-27 0000-00-00 No No Current 70771-1016-4 70771101604 10 BLISTER PACK in 1 CARTON (70771-1016-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1016-2) 10 blister pack 2016-10-27 0000-00-00 No No Current 70771-1016-5 70771101605 500 TABLET, FILM COATED in 1 BOTTLE (70771-1016-5) 2016-10-27 0000-00-00 No No Current 70771-1016-9 70771101609 90 TABLET, FILM COATED in 1 BOTTLE (70771-1016-9) 2016-10-27 0000-00-00 No No Current