Home NDC 13668-356 nebivolol
Product NDC 13668-356
11-digit product format 136680356
Labeler code 13668
Product ID 13668-356_dd21623c-b76b-415e-9be7-d423f6719096
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nebivolol
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA203966
Marketing category ANDA
Marketing start 2018-03-02
Marketing end 0000-00-00
Substance NEBIVOLOL HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203966-001 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL 2018-03-02 A203966-002 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-03-02 A203966-003 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-03-02 A203966-004 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-03-02
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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203966-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203966-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203966-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203966-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2018-03-02 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 128 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-356 NEBIVOLOL TABLET [TORRENT PHARMACEUTICALS LIMITED] 18 Legacy NDC 20241213_3e3dc363-731f-4115-b685-a17620dd2034.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-356-01 13668035601 100 TABLET in 1 BOTTLE (13668-356-01) 100 tablet 2021-08-19 0000-00-00 No No Current 13668-356-05 13668035605 500 TABLET in 1 BOTTLE (13668-356-05) 500 tablet 2018-03-02 0000-00-00 No No Current 13668-356-30 13668035630 30 TABLET in 1 BOTTLE (13668-356-30) 30 tablet 2018-03-02 0000-00-00 No No Current 13668-356-74 13668035674 100 TABLET in 1 CARTON (13668-356-74) 100 tablet 2021-08-19 0000-00-00 No No Current 13668-356-90 13668035690 90 TABLET in 1 BOTTLE (13668-356-90) 90 tablet 2021-06-17 0000-00-00 No No Current