Home NDC 70710-1069 VARDENAFIL
Product NDC 70710-1069
11-digit product format 707101069
Labeler code 70710
Product ID 70710-1069_a6417d62-c65a-49a5-a3c7-d9d178a36cb9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VARDENAFIL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208960
Marketing category ANDA
Marketing start 2018-11-01
Substance VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Active strength 5 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A208960-001 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 A208960-002 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 A208960-003 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 A208960-004 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 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 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base VARDENAFIL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARDENAFIL HYDROCHLORIDE TRIHYDRATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5M8S2CU0TS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349478 Internal RxNorm lookup 349479 Internal RxNorm lookup 349480 Internal RxNorm lookup 402273 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 70710-1069-1 VARDENAFIL 100 in 1 BOTTLE TABLET, FILM COATED 100 6 70710-1069-3 VARDENAFIL 30 in 1 BOTTLE TABLET, FILM COATED 30 6 70710-1069-9 VARDENAFIL 90 in 1 BOTTLE TABLET, FILM COATED 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1069 VARDENAFIL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 3 package rows 20230613_5876e062-e604-42a7-99c3-5da30b8dac06.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70710-1069-1 70710106901 100 TABLET, FILM COATED in 1 BOTTLE (70710-1069-1) 2018-11-01 0000-00-00 No No Current 70710-1069-3 70710106903 30 TABLET, FILM COATED in 1 BOTTLE (70710-1069-3) 2018-11-01 0000-00-00 No No Current 70710-1069-9 70710106909 90 TABLET, FILM COATED in 1 BOTTLE (70710-1069-9) 2018-11-01 0000-00-00 No No Current