Sildenafil

Product NDC: 43353-345
11-digit product format: 433530345
Labeler code: 43353
Product ID: 43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA021845
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-09-27
Substance: SILDENAFIL CITRATE
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-345		D	Discontinued by firm	2026-08-17
excluded package	package	43353-345	43353-345-10	D	Discontinued by firm	2026-08-17
excluded package	package	43353-345	43353-345-20	D	Discontinued by firm	2026-08-17
excluded package	package	43353-345	43353-345-53	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021845-001	REVATIO	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021845-001	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N021845-001	M-287	2026-01-31
N021845-001	ODE-469	2030-01-31

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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021845-001	REVATIO	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2005-06-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021845-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021845-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021845-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021845-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021845-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021845-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021845-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021845-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021845-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021845-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021845-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021845-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021845-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021845-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021845-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021845-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021845-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021845-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021845-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021845-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021845-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021845-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021845-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021845-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021845-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021845-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021845-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021845-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021845-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021845-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021845-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021845-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021845-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021845-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021845-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021845-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021845-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021845-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021845-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021845-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N021845-001	M-287	2026-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021845-001	ODE-469	2030-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021845-001	M-287	2026-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021845-001	ODE-469	2030-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021845-001	M-287	2026-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021845-001	ODE-469	2030-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021845-001	M-287	2026-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021845-001	ODE-469	2030-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021845-001	M-287	2026-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021845-001	ODE-469	2030-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021845-001	M-287	2026-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021845-001	ODE-469	2030-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021845-001	M-287	2026-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021845-001	ODE-469	2030-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021845-001	M-287	2026-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021845-001	ODE-469	2030-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021845-001	M-287	2026-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021845-001	ODE-469	2030-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021845-001	M-287	2026-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021845-001	ODE-469	2030-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021845-001	M-287	2026-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021845-001	ODE-469	2030-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021845-001	M-287	2026-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021845-001	ODE-469	2030-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021845-001	M-287	2026-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021845-001	ODE-469	2030-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021845-001	M-287	2026-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021845-001	ODE-469	2030-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021845-001	M-287	2026-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021845-001	ODE-469	2030-01-31	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021845-001	M-287	2026-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021845-001	M-287	2026-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021845-001	M-287	2026-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021845-001	M-287	2026-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021845-001	M-287	2026-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021845-001	M-287	2026-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021845-001	M-287	2026-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021845-001	M-287	2026-01-31	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021845-001	M-287	2026-01-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021845-001	ODE-469	2030-01-31	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fabccea2-36c8-9268-ee44-ec231455538f	Product name	9	20241217
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-345-10	Sildenafil	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
43353-345-20	Sildenafil	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
43353-345-53	Sildenafil	60 in 1 BOTTLE	TABLET, FILM COATED	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-345-10	EA - Each	43353-345	876cfb4f-a8e8-4205-9e35-376ca2a7021f	1	2017-12-14
43353-345-20	EA - Each	43353-345	2df97703-4ba1-42aa-86e1-1d7d3c8fd169	1	2017-12-14
43353-345-53	EA - Each	43353-345	2a9f5a88-ba8e-436a-b28a-a2c9a42083ba	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-345	SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 3 package rows	20170706_761f9606-2583-439a-a29e-736008340a9e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Revatio	SILDENAFIL CITRATE	Viatris Specialty LLC	3bb9363e-b28d-4019-8aae-539233dca214	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021845 application number: NDA021845
Revatio	SILDENAFIL CITRATE	PFIZER LABORATORIES DIV PFIZER INC	f158fe10-d5dc-4432-b2c9-fc665401291b	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021845 application number: NDA021845

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577033	sildenafil citrate 20 MG Oral Tablet	PSN	761f9606-2583-439a-a29e-736008340a9e	1
577033	sildenafil 20 MG Oral Tablet	SCD	761f9606-2583-439a-a29e-736008340a9e	1
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	761f9606-2583-439a-a29e-736008340a9e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-345-10	43353034510	10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10)	2017-07-03	0000-00-00	No	No	Current
43353-345-20	43353034520	20 TABLET, FILM COATED in 1 BOTTLE (43353-345-20)	2017-07-03	0000-00-00	No	No	Current
43353-345-53	43353034553	60 TABLET, FILM COATED in 1 BOTTLE (43353-345-53)	2017-07-03	0000-00-00	No	No	Current