National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 01:34:31

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-748-52	EA - Each	43353-748	3deb1d2e-653a-41e8-960a-e2739688778d	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43353-748	43353-748-52

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19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LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19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LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19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LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021400-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021400-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021400-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021400-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021400-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021400-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021400-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021400-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021400-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021400-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021400-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021400-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021400-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021400-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021400-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021400-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021400-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021400-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021400-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021400-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021400-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021400-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021400-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021400-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021400-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021400-004	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 268 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021400-002	8273876	2027-07-23	U-1288		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021400-003	8273876	2027-07-23	U-1288		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021400-004	8273876	2027-07-23	U-1288		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021400-002	8273876	2027-07-23	U-1288		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021400-003	8273876	2027-07-23	U-1288		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021400-004	8273876	2027-07-23	U-1288		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-002	8273876	2027-07-23	U-1288		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-003	8273876	2027-07-23	U-1288		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-004	8273876	2027-07-23	U-1288		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-002	8273876	2027-07-23	U-1288		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-003	8273876	2027-07-23	U-1288		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-004	8273876	2027-07-23	U-1288		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-002	8273876	2027-07-23	U-1288		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-003	8273876	2027-07-23	U-1288		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-004	8273876	2027-07-23	U-1288		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-002	8273876	2027-07-23	U-1288		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-003	8273876	2027-07-23	U-1288		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-004	8273876	2027-07-23	U-1288		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-002	8273876	2027-07-23	U-1288		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-003	8273876	2027-07-23	U-1288		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-004	8273876	2027-07-23	U-1288		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-002	8273876	2027-07-23	U-1288		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-003	8273876	2027-07-23	U-1288		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-004	8273876	2027-07-23	U-1288		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-002	8273876	2027-07-23	U-1288		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-003	8273876	2027-07-23	U-1288		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-004	8273876	2027-07-23	U-1288		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-002	8273876	2027-07-23	U-1288		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-003	8273876	2027-07-23	U-1288		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-004	8273876	2027-07-23	U-1288		`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.