FDA.reportPublic FDA data

Vardenafil hydrochloride

Product NDC
69238-1152
11-digit product format
692381152
Labeler code
69238
Product ID
69238-1152_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
10 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69238-1152DDiscontinued by firm2026-07-31
excluded packagepackage69238-115269238-1152-3DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210738-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2018-10-31
A210738-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2018-10-31
A210738-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2018-10-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210738-001VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A210738-002VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A210738-003VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2018-10-31a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1152-36923811520330 TABLET, FILM COATED in 1 BOTTLE (69238-1152-3) 2018-10-310000-00-00NoNoCurrent