Home NDC 0591-3355 Nateglinide
Product NDC 0591-3355
11-digit product format 005913355
Labeler code 0591
Product ID 0591-3355_ead87332-2796-4cae-b377-5e54aae8a3ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nateglinide
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA077462
Marketing category ANDA
Marketing start 2011-05-18
Marketing end 0000-00-00
Substance NATEGLINIDE
Active strength 120 mg/1
Pharmacologic classes Glinide [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A077462-001 NATEGLINIDE NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 A077462-002 NATEGLINIDE NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30
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 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077462-001 NATEGLINIDE 60MG TABLET / ORAL AB 2011-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077462-002 NATEGLINIDE 120MG TABLET / ORAL AB 2011-03-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NATEGLINIDE ACTIVE INGREDIENT 41X3PWK4O2 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 NATEGLINIDE ACTIVE MOIETY 41X3PWK4O2 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 FERRIC OXIDE BLACK INACTIVE INGREDIENT XM0M87F357 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 FUMARIC ACID INACTIVE INGREDIENT 88XHZ13131 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NATEGLINIDE TABLET [WATSON LABORATORIES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3355 NATEGLINIDE TABLET [ACTAVIS PHARMA, INC.] 11 Legacy NDC 20230805_a7e9f62e-32f8-4a89-8588-74d029c8f6a2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-3355-01 00591335501 100 TABLET in 1 BOTTLE, PLASTIC (0591-3355-01) 100 tablet 2011-05-18 0000-00-00 No No Current