Revatio

Product NDC: 0069-0338
11-digit product format: 000690338
Labeler code: 0069
Product ID: 0069-0338_eeeb2d77-bc88-45e8-afb2-f18cc8aa941e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil citrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA022473
Marketing category: NDA
Marketing start: 2009-11-18
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 1 mg/mL
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0069-0338		D	Discontinued by firm		2026-08-17
excluded package	package	0069-0338	0069-0338-01	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
N022473-001	REVATIO	SILDENAFIL CITRATE	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022473-001	AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022473-001	M-287	2026-01-31

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	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022473-001	REVATIO	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2009-11-18	`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	N022473-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022473-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022473-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022473-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022473-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022473-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022473-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022473-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022473-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022473-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022473-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022473-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022473-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022473-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022473-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022473-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022473-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022473-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022473-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022473-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022473-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022473-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022473-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022473-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022473-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022473-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022473-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022473-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022473-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022473-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022473-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022473-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022473-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022473-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022473-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022473-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022473-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022473-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022473-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022473-001	AP	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	N022473-001	M-287	2026-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022473-001	M-287	2026-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022473-001	M-287	2026-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022473-001	M-287	2026-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022473-001	M-287	2026-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022473-001	M-287	2026-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022473-001	M-287	2026-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022473-001	M-287	2026-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022473-001	M-287	2026-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022473-001	M-287	2026-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022473-001	M-287	2026-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022473-001	M-287	2026-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022473-001	M-287	2026-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022473-001	M-287	2026-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022473-001	M-287	2026-01-31	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022473-001	M-287	2026-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022473-001	M-287	2026-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022473-001	M-287	2026-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022473-001	M-287	2026-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022473-001	M-287	2026-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022473-001	M-287	2026-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022473-001	M-287	2026-01-31	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022473-001	M-287	2026-01-31	`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	Strength	SPL version
0069-0338-01	Revatio	12.5 mL in 1 VIAL	INJECTION, SOLUTION	12.5		45
0069-0338-01	Revatio	1 in 1 CARTON	INJECTION, SOLUTION	1		45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-0338-01	ML - Milliliter	0069-0338	f2af65ee-e6a0-4818-b407-9cdb55573cd2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SILDENAFIL CITRATE	ACTIVE INGREDIENT	BW9B0ZE037	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
SILDENAFIL	ACTIVE MOIETY	3M7OB98Y7H	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
SORBITOL	INACTIVE INGREDIENT	506T60A25R	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
WATER	INACTIVE INGREDIENT	059QF0KO0R	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-0338	REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]	44	Legacy NDC, 2 package rows	20250410_f158fe10-d5dc-4432-b2c9-fc665401291b.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): 022473 application number: NDA022473
Revatio	SILDENAFIL CITRATE	PFIZER LABORATORIES DIV PFIZER INC	f158fe10-d5dc-4432-b2c9-fc665401291b	2023-01-27	Warnings, Adverse reactions	Exact identifier ndc (product): 0069-0338

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	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882530	Revatio 10 MG in 12.5 ML Injection	PSN	f158fe10-d5dc-4432-b2c9-fc665401291b	45
581645	Revatio 20 MG Oral Tablet	PSN	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307427	sildenafil 10 MG in 1 mL Oral Suspension	PSN	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882527	sildenafil 10 MG in 12.5 ML Injection	PSN	f158fe10-d5dc-4432-b2c9-fc665401291b	45
577033	sildenafil citrate 20 MG Oral Tablet	PSN	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882530	12.5 ML sildenafil 0.8 MG/ML Injection [Revatio]	SBD	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307431	sildenafil 10 MG/ML Oral Suspension [Revatio]	SBD	f158fe10-d5dc-4432-b2c9-fc665401291b	45
581645	sildenafil 20 MG Oral Tablet [Revatio]	SBD	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882527	12.5 ML sildenafil 0.8 MG/ML Injection	SCD	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307427	sildenafil 10 MG/ML Oral Suspension	SCD	f158fe10-d5dc-4432-b2c9-fc665401291b	45
577033	sildenafil 20 MG Oral Tablet	SCD	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882530	12.5 ML Revatio 0.8 MG/ML Injection	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882530	Revatio (as sildenafil citrate) 10 MG per 12.5 ML Injection	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307431	Revatio (as sildenafil citrate) 10 MG/ML Powder for Oral Suspension	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307431	Revatio 10 MG per 1 ML Oral Suspension	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307431	Revatio 10 MG/ML Oral Suspension	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
581645	Revatio 20 MG (as sildenafil citrate) Oral Tablet	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
581645	Revatio 20 MG Oral Tablet	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882527	sildenafil (as sildenafil citrate) 10 MG per 12.5 ML Injection	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307427	sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral Suspension	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
1307427	sildenafil 10 MG per 1 ML Oral Suspension	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
882527	sildenafil 10 MG per 12.5 ML Injection	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	f158fe10-d5dc-4432-b2c9-fc665401291b	45

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-0338-01	00069033801	1 VIAL in 1 CARTON (0069-0338-01) > 12.5 mL in 1 VIAL	1 vial	2009-11-18	0000-00-00	No	No	Current