SILDENAFIL

Product NDC: 61919-826
Requested package NDC: 61919-826-20
11-digit product format: 619190826
Labeler code: 61919
Product ID: 61919-826_eac53773-083b-5f20-e053-2a95a90a2b6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILDENAFIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA203814
Marketing category: ANDA
Marketing start: 2016-08-29
Marketing end: 0000-00-00
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-826	61919-826-20	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A203814-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2013-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203814-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`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	A203814-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203814-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203814-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203814-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203814-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203814-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203814-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203814-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203814-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203814-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203814-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203814-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203814-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203814-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203814-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203814-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203814-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203814-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203814-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203814-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203814-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203814-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203814-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203814-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203814-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203814-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203814-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203814-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203814-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203814-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203814-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203814-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203814-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203814-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203814-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203814-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203814-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203814-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203814-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203814-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-826-10	2025-01-30	2cef2736-6e10-d83d-e063-dadaa90ab31f	SILDENAFIL
61919-826-20	2025-01-30	2cef2736-6e10-d83d-e063-dadaa90ab31f	SILDENAFIL
61919-826-30	2025-01-30	2cef2736-6e10-d83d-e063-dadaa90ab31f	SILDENAFIL
61919-826-50	2025-01-30	2cef2736-6e10-d83d-e063-dadaa90ab31f	SILDENAFIL
61919-826-90	2020-01-31	9d75b9d0-d273-f424-e053-dadaa90a57ce	SILDENAFIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-826-10	SILDENAFIL	10 in 1 BOTTLE	TABLET, FILM COATED	10	11
61919-826-20	SILDENAFIL	20 in 1 BOTTLE	TABLET, FILM COATED	20	11
61919-826-30	SILDENAFIL	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
61919-826-50	SILDENAFIL	50 in 1 BOTTLE	TABLET, FILM COATED	50	11
61919-826-90	SILDENAFIL	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-826-10	EA - Each	61919-826	1f59faa3-c0ef-466b-8825-5b3e693c7cd9	1	2019-11-12
61919-826-15	EA - Each	61919-826	e8159d6a-6fe5-4fad-98fb-c3bd3aadbf83	1	2019-11-12
61919-826-20	EA - Each	61919-826	1f6b53a1-952b-4f54-ae72-1808f1eb8f0e	1	2022-11-07
61919-826-30	EA - Each	61919-826	579f2eb5-f837-4117-a94d-2895d0177d25	1	2019-11-12
61919-826-50	EA - Each	61919-826	3536b2d8-adb3-4db6-a9c0-940a274c952d	1	2019-08-06
61919-826-90	EA - Each	61919-826	40557455-f8e7-42a6-a608-3dcf09640d34	1	2016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SILDENAFIL CITRATE	ACTIVE INGREDIENT	BW9B0ZE037	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
SILDENAFIL	ACTIVE MOIETY	3M7OB98Y7H	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-826	SILDENAFIL TABLET, FILM COATED [DIRECT RX]	11	Legacy NDC, 4 package rows	20230524_3b3aae0f-4d1d-0244-e054-00144ff88e88.zip
61919-826	SILDENAFIL TABLET, FILM COATED [DIRECTRX]	1	Legacy NDC, 1 package rows	20151020_c152953d-53a0-4f8b-91d7-fcd94024ad49.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	American Health Packaging	f7fbfc3b-807e-4375-a6eb-8db0eaf40c9c	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Macleods Pharmaceuticals Limited	61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e	2025-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	BluePoint Laboratories	be6d1015-306d-44fb-8d4d-01724b8d9590	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	46dff4c0-9a6c-20f9-e054-00144ff8d46c	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	97ccea8a-6d5a-129f-e053-2995a90aa837	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	72900ed9-dbab-3f7b-e053-2a91aa0a0d24	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	7c01fd56-5dd6-4728-9f2a-e0f5db810269	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Macleods Pharmaceuticals Limited	d2892f4b-f5ba-42f5-b373-310241f4efa7	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Asclemed USA, Inc.	06571775-b651-4e23-a35b-88392aae7e13	2022-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	85767ed7-932b-4e2b-8bba-b59bb45ce116	2020-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Proficient Rx LP	2538995d-2df6-4c87-978a-5513c670b60f	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE
3M7OB98Y7H	SILDENAFIL	139755-83-2	SILDENAFIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577033	sildenafil citrate 20 MG Oral Tablet	PSN	3b3aae0f-4d1d-0244-e054-00144ff88e88	11
312950	sildenafil citrate 50 MG Oral Tablet	PSN	3b3aae0f-4d1d-0244-e054-00144ff88e88	11
577033	sildenafil 20 MG Oral Tablet	SCD	3b3aae0f-4d1d-0244-e054-00144ff88e88	11
312950	sildenafil 50 MG Oral Tablet	SCD	3b3aae0f-4d1d-0244-e054-00144ff88e88	11
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	3b3aae0f-4d1d-0244-e054-00144ff88e88	11
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	3b3aae0f-4d1d-0244-e054-00144ff88e88	11
577033	sildenafil citrate 20 MG Oral Tablet	PSN	c152953d-53a0-4f8b-91d7-fcd94024ad49	1
577033	sildenafil 20 MG Oral Tablet	SCD	c152953d-53a0-4f8b-91d7-fcd94024ad49	1
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	c152953d-53a0-4f8b-91d7-fcd94024ad49	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-826-20	61919082620	20 TABLET, FILM COATED in 1 BOTTLE (61919-826-20)	2016-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SILDENAFIL	DIRECT RX	2023-05-23	HUMAN PRESCRIPTION DRUG LABEL	11
SILDENAFIL	DirectRX	2015-10-20	HUMAN PRESCRIPTION DRUG LABEL	1