Revatio

Product NDC: 58151-402
11-digit product format: 581510402
Labeler code: 58151
Product ID: 58151-402_3fa2b889-ff04-4db1-b2c8-c0238efe240b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA021845
Marketing category: NDA
Marketing start: 2024-10-25
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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Revatio
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILDENAFIL CITRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BW9B0ZE037	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
577033	Internal RxNorm lookup
581645	Internal RxNorm lookup
882527	Internal RxNorm lookup
882530	Internal RxNorm lookup
1307427	Internal RxNorm lookup
1307431	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3bb9363e-b28d-4019-8aae-539233dca214	Available on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58151-402-77	Revatio	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58151-402	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [VIATRIS SPECIALTY LLC]	3	Current NDC, 1 package rows	20250410_3bb9363e-b28d-4019-8aae-539233dca214.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 ndc (product): 58151-402
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
1307431	Revatio 10 MG in 1 mL Oral Suspension	PSN	3bb9363e-b28d-4019-8aae-539233dca214	4
882530	Revatio 10 MG in 12.5 ML Injection	PSN	3bb9363e-b28d-4019-8aae-539233dca214	4
581645	Revatio 20 MG Oral Tablet	PSN	3bb9363e-b28d-4019-8aae-539233dca214	4
1307427	sildenafil 10 MG in 1 mL Oral Suspension	PSN	3bb9363e-b28d-4019-8aae-539233dca214	4
882527	sildenafil 10 MG in 12.5 ML Injection	PSN	3bb9363e-b28d-4019-8aae-539233dca214	4
577033	sildenafil citrate 20 MG Oral Tablet	PSN	3bb9363e-b28d-4019-8aae-539233dca214	4
882530	12.5 ML sildenafil 0.8 MG/ML Injection [Revatio]	SBD	3bb9363e-b28d-4019-8aae-539233dca214	4
1307431	sildenafil 10 MG/ML Oral Suspension [Revatio]	SBD	3bb9363e-b28d-4019-8aae-539233dca214	4
581645	sildenafil 20 MG Oral Tablet [Revatio]	SBD	3bb9363e-b28d-4019-8aae-539233dca214	4
882527	12.5 ML sildenafil 0.8 MG/ML Injection	SCD	3bb9363e-b28d-4019-8aae-539233dca214	4
1307427	sildenafil 10 MG/ML Oral Suspension	SCD	3bb9363e-b28d-4019-8aae-539233dca214	4
577033	sildenafil 20 MG Oral Tablet	SCD	3bb9363e-b28d-4019-8aae-539233dca214	4
882530	12.5 ML Revatio 0.8 MG/ML Injection	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
882530	Revatio (as sildenafil citrate) 10 MG per 12.5 ML Injection	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
1307431	Revatio (as sildenafil citrate) 10 MG/ML Powder for Oral Suspension	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
1307431	Revatio 10 MG per 1 ML Oral Suspension	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
1307431	Revatio 10 MG/ML Oral Suspension	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
581645	Revatio 20 MG (as sildenafil citrate) Oral Tablet	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
581645	Revatio 20 MG Oral Tablet	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
882527	sildenafil (as sildenafil citrate) 10 MG per 12.5 ML Injection	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
1307427	sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral Suspension	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
1307427	sildenafil 10 MG per 1 ML Oral Suspension	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
882527	sildenafil 10 MG per 12.5 ML Injection	SY	3bb9363e-b28d-4019-8aae-539233dca214	4
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	3bb9363e-b28d-4019-8aae-539233dca214	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Status
58151-402-77	58151040277	90 TABLET, FILM COATED in 1 BOTTLE (58151-402-77)	2026-06-22	0	Current