Vardenafil Hydrochloride

Product NDC
73750-102
Requested package NDC
73750-102-30
11-digit product format
737500102
Labeler code
73750
Product ID
73750-102_db8e52bb-02ac-9e93-e053-2a95a90a7c85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
QYK BRANDS LLC
Application
ANDA204632
Marketing category
ANDA
Marketing start
2022-03-01
Marketing end
0000-00-00
Substance
VARDENAFIL
Active strength
3 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage73750-10273750-102-30IInactivated by FDA2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204632-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22
A204632-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22
A204632-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22
A204632-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204632-001AB
A204632-002AB
A204632-003AB
A204632-004AB

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 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204632-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204632-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204632-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204632-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204632-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204632-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204632-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204632-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204632-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204632-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204632-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204632-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204632-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204632-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204632-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204632-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204632-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204632-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204632-004AB1d06236e962d9…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEMacleods Pharmaceuticals Limiteda38de6e1-21ca-4ebe-a3c7-6f849cf8b6752023-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204632
application number: ANDA204632

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73750-102-10Vardenafil Hydrochloride100 in 1 BOTTLETABLET1002
73750-102-11Vardenafil Hydrochloride10 in 1 CARTONTABLET102
73750-102-11Vardenafil Hydrochloride10 in 1 BLISTER PACKTABLET102
73750-102-30Vardenafil Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73750-102VARDENAFIL HYDROCHLORIDE TABLET [QYK BRANDS LLC]2Legacy NDC, 4 package rows20220402_db63310a-37f3-202b-e053-2995a90a5520.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil HCl 10 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil HCl 2.5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73750-102-307375001023030 TABLET in 1 BOTTLE (73750-102-30) 30 tablet2022-03-010000-00-00NoNoCurrent