Home NDC 69238-1153 Vardenafil hydrochloride
Product NDC 69238-1153
11-digit product format 692381153
Labeler code 69238
Product ID 69238-1153_e7ac5c33-4141-4360-a713-38ee40e7b390
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vardenafil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA210738
Marketing category ANDA
Marketing start 2018-10-31
Marketing end 0000-00-00
Substance VARDENAFIL HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210738-001 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 A210738-002 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 A210738-003 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31
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 · 108 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 2025-01-19 17:59 UTC 2025-01 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC 2025-01 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC 2025-01 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210738-002 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL 2018-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210738-003 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL 2018-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210738-001 VARDENAFIL HYDROCHLORIDE 5MG TABLET / ORAL 2018-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210738-002 VARDENAFIL HYDROCHLORIDE 10MG TABLET / ORAL 2018-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210738-003 VARDENAFIL HYDROCHLORIDE 20MG TABLET / ORAL 2018-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210738-001 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2018-10-31 bb7c543d1eb4…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69238-1153-3 69238115303 30 TABLET, FILM COATED in 1 BOTTLE (69238-1153-3) 2018-10-31 0000-00-00 No No Current