Levitra

Product NDC: 43353-748
11-digit product format: 433530748
Labeler code: 43353
Product ID: 43353-748_95bf61f7-6238-4b01-b70e-df731b5f642b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vardenafil hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
Application: NDA021400
Marketing category: NDA
Marketing start: 2011-04-22
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: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-748		I	Inactivated by FDA	2026-07-31
excluded package	package	43353-748	43353-748-02	I	Inactivated by FDA	2026-07-31
excluded package	package	43353-748	43353-748-04	I	Inactivated by FDA	2026-07-31
excluded package	package	43353-748	43353-748-06	I	Inactivated by FDA	2026-07-31
excluded package	package	43353-748	43353-748-12	I	Inactivated by FDA	2026-07-31
excluded package	package	43353-748	43353-748-52	I	Inactivated by FDA	2026-07-31
excluded package	package	43353-748	43353-748-79	I	Inactivated by FDA	2026-07-31

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	RLD / RS	Approval date
N021400-001	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19
N021400-002	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19
N021400-003	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19
N021400-004	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021400-001	8273876	2027-07-23	U-1288	2012-10-24
N021400-002	8273876	2027-07-23	U-1288
N021400-003	8273876	2027-07-23	U-1288
N021400-004	8273876	2027-07-23	U-1288

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021400-002	8273876	2027-07-23	U-1288		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021400-003	8273876	2027-07-23	U-1288		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021400-004	8273876	2027-07-23	U-1288		`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f2f15561-f1f1-39f4-fff4-873c88c535cd	Product name	4	20210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17	Product name	3	20200708

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-748-02	2019-11-13	C162847	48780-1	97449f38-c65f-f6ea-e053-dbdaa90aa703	Vardenafil HCl (Levitra ® ) Tablets
43353-748-04	2019-11-13	C162847	48780-1	97449f38-c65f-f6ea-e053-dbdaa90aa703	Vardenafil HCl (Levitra ® ) Tablets
43353-748-06	2019-11-13	C162847	48780-1	97449f38-c65f-f6ea-e053-dbdaa90aa703	Vardenafil HCl (Levitra ® ) Tablets
43353-748-12	2019-11-13	C162847	48780-1	97449f38-c65f-f6ea-e053-dbdaa90aa703	Vardenafil HCl (Levitra ® ) Tablets
43353-748-52	2019-11-13	C162847	48780-1	97449f38-c65f-f6ea-e053-dbdaa90aa703	Vardenafil HCl (Levitra ® ) Tablets
43353-748-79	2019-11-13	C162847	48780-1	97449f38-c65f-f6ea-e053-dbdaa90aa703	Vardenafil HCl (Levitra ® ) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-748-02	Levitra	2 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	2	1
43353-748-04	Levitra	4 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	4	1
43353-748-06	Levitra	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6	1
43353-748-12	Levitra	12 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	12	1
43353-748-52	Levitra	18 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	18	1
43353-748-79	Levitra	2160 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	2160	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-748-02	EA - Each	43353-748	e7c7f34f-6c49-4a75-b858-3d314a02a1b5	1	2012-07-24
43353-748-04	EA - Each	43353-748	11fc804f-3154-4ab1-9b62-e0952337dbdf	1	2012-07-24
43353-748-06	EA - Each	43353-748	36d3f412-51ae-4ca7-9171-c0224a816019	1	2012-07-24
43353-748-12	EA - Each	43353-748	34ce2b1f-b236-47c5-b35c-04c23c446bfd	1	2012-07-24
43353-748-52	EA - Each	43353-748	3deb1d2e-653a-41e8-960a-e2739688778d	1	2012-07-24
43353-748-79	EA - Each	43353-748	7fc34788-c347-475b-bec9-5636f0270f45	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VARDENAFIL HYDROCHLORIDE	ACTIVE INGREDIENT	5M8S2CU0TS	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
VARDENAFIL	ACTIVE MOIETY	UCE6F4125H	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-748	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 6 package rows	20111027_4e66ad5c-572c-4819-8b6e-6930c33cc210.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5M8S2CU0TS	VARDENAFIL HYDROCHLORIDE	330808-88-3	VARDENAFIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
404638	LEVITRA 10 MG Oral Tablet	PSN	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404639	LEVITRA 20 MG Oral Tablet	PSN	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404637	LEVITRA 5 MG Oral Tablet	PSN	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349480	vardenafil 20 MG Oral Tablet	PSN	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349478	vardenafil 5 MG Oral Tablet	PSN	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349479	vardenafil HCl 10 MG Oral Tablet	PSN	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404638	vardenafil 10 MG Oral Tablet [Levitra]	SBD	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404639	vardenafil 20 MG Oral Tablet [Levitra]	SBD	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404637	vardenafil 5 MG Oral Tablet [Levitra]	SBD	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349479	vardenafil 10 MG Oral Tablet	SCD	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349480	vardenafil 20 MG Oral Tablet	SCD	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349478	vardenafil 5 MG Oral Tablet	SCD	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404639	Levitra (as vardenafil HCl) 20 MG Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404638	Levitra (as vardenafil hydrochloride) 10 MG Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404637	Levitra (as vardenafil hydrochloride) 5 MG Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404638	Levitra 10 MG Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404639	Levitra 20 MG Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
404637	Levitra 5 MG Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349479	vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349480	vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1
349478	vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral Tablet	SY	4e66ad5c-572c-4819-8b6e-6930c33cc210	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-748-02	43353074802	2 in 1 BOTTLE, PLASTIC	Historical
43353-748-04	43353074804	4 in 1 BOTTLE, PLASTIC	Historical
43353-748-06	43353074806	6 in 1 BOTTLE, PLASTIC	Historical
43353-748-12	43353074812	12 in 1 BOTTLE, PLASTIC	Historical
43353-748-52	43353074852	18 in 1 BOTTLE, PLASTIC	Historical
43353-748-79	43353074879	2160 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vardenafil HCl (Levitra ® ) Tablets	APHENA PHARMA SOLUTIONS - TENNESSEE, INC. \| Bayer HealthCare Pharmaceuticals Inc. \| Bayer Schering Pharma AG	2011-10-27	HUMAN PRESCRIPTION DRUG LABEL	1