sildenafil citrate

Manufacturer: CarePartners Pharmacy, LLC
Effective date: 2019-08-23
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 00:14:01

Label at a glance#

ProductTadalafil

Active ingredientTADALAFIL, SILDENAFIL CITRATE

Label structure4 sections

Label contents#

Full prescribing information#

Description of Sildenafil 5 mg and 100 mg Tablets

DESCRIPTION SECTION

11. DESCRIPTION Sildenafil Tablets, USP phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:

Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder. Slightly soluble in water & methanol, practically insoluble in hexane and a molecular weight of 666.7. Sildenafil tablets: Sildenafil tablets is white round, biconvex film coated tablets, debossed with R on one side and 20 on the other, containing sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate , each tablet contains the following inactive ingredients: Crospovidone, Hypromellose, Hydrophobic colloidal silica, Lactose monohydrate, Magnesium stearate, Microcrystalline cellulose, Titanium dioxide, and Triacetin.

Description of Tadalafil 5 mg and 20 mg Tablets

DESCRIPTION SECTION

Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C H N O representing a molecular weight of 389.41. The structural formula is:

The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5yl)2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water Tadalafil Tablets USP are available as oval / almond shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients : Lactose monohydrate, Microcrystalline Cellulose, Sodium Lauryl Sulphate, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc and Yellow iron oxide. In addition, Tadalafil Tablets, 2.5 mg and 10 mg contains Red iron oxide

Sildenafil 20 mg and 100 mg oackage label.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sildenafil 20 mg LabelSildenafil 100 mg Label

Tadalafil 5 mg and 20 mg Tablet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tadalafil 5 mg TabletTadalafil 20 mg Tablet

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-289-05	EA - Each	29300-289	4e4a3a5a-56e2-4ff3-8ad6-8bfd9866b6d8	1	2024-05-16
29300-289-13	EA - Each	29300-289	8988a1a7-8ed0-4290-b7f8-48c72ebf1bad	1	2019-04-11
42543-005-10	EA - Each	42543-005	6569235d-3496-4396-96ca-b82f2b9e2174	1	2017-08-11
42543-005-90	EA - Each	42543-005	32b7cb01-8f0b-46d4-bfb4-06ebfcbb8748	1	2017-04-05
29300-287-05	EA - Each	29300-287	826d4b5d-8ac8-45c2-b831-046eed0e4109	1	2021-08-05
29300-287-13	EA - Each	29300-287	438f7c13-d062-44bb-875d-e0b593061b78	1	2019-04-11
29300-287-51	EA - Each	29300-287	7293b1ab-c249-4807-ab1c-3c6028846522	1	2019-04-11
29300-287-82	EA - Each	29300-287	c3a3cbc7-09cc-4494-b9f7-e4f9e56a7183	1	2019-04-11
60219-1753-3	EA - Each	60219-1753	7a949024-1edd-451b-85cf-2f18ae1c672c	1	2018-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Tadalafil
sildenafil
SILDENAFIL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73160-001	73160-001-30, 73160-001-60
73160-005	73160-005-12, 73160-005-25
73160-010	73160-010-30, 73160-010-60
73160-015	73160-015-12, 73160-015-25
29300-289
42543-005
29300-287
60219-1753

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TADALAFIL	742SXX0ICT	ACTIB
SILDENAFIL CITRATE	BW9B0ZE037	ACTIM
TADALAFIL	742SXX0ICT	ACTIB
SILDENAFIL CITRATE	BW9B0ZE037	ACTIM

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 · 3 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202023-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27
A202023-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27
A202023-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202023-001	AB
A202023-002	AB
A202023-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202023-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202023-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202023-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202023-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202023-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-001	AB	1	`301d65b070ca…`

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

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
A204883-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2016-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204883-001	AB

Observed Orange Book product history#

Product history page 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204883-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204883-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204883-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204883-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204883-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204883-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204883-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204883-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204883-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204883-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204883-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204883-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204883-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204883-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204883-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204883-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204883-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204883-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204883-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204883-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204883-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204883-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204883-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204883-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204883-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204883-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204883-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204883-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204883-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204883-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204883-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204883-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204883-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204883-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204883-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204883-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204883-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204883-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204883-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204883-001	AB	1	`f41ea6bd6efb…`

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	TE codes	Approval date
A209250-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209250-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209250-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209250-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A209250-001	AB1
A209250-002	AB1
A209250-003	AB1
A209250-004	AB1

Observed Orange Book product history#

Product history page 1 of 5 · 172 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
2026-09-14 22:38:34	2026-08	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209250-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209250-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209250-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209250-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209250-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209250-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209250-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209250-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209250-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209250-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209250-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209250-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209250-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209250-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209250-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209250-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209250-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209250-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209250-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209250-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209250-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209250-004	AB1	1	`5bbf6a4d5a75…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	Amneal Pharmaceuticals NY LLC	a1c3a2a2-8cf5-41c3-9c86-54290570d916	2026-07-06	Warnings, Adverse reactions	Exact identifier ndc (product): 60219-1753
tadalafil	TADALAFIL	Unichem Pharmaceuticals (USA), Inc.	a7b3937e-ff03-436a-a5d4-92a4771034b6	2024-01-31	Warnings, Adverse reactions	Exact identifier ndc (product): 29300-289 ndc (product): 29300-287
96f510aa-b2f2-6e76-e053-2995a90a5255			90cd56e2-b575-f061-e053-2995a90afd98	2019-11-09		Exact identifier spl set id: 90cd56e2-b575-f061-e053-2995a90afd98

Reported adverse events (FAERS/openFDA)#

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