Sildenafil

Product NDC: 72303-0847
11-digit product format: 723030847
Labeler code: 72303
Product ID: 72303-0847_4c5653c7-ab90-28e5-e063-6394a90af1f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: HEC Pharm USA Inc.
Application: ANDA213032
Marketing category: ANDA
Marketing start: 2020-06-11
Substance: SILDENAFIL CITRATE
Active strength: 100 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

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

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72303-0847	72303-0847-2	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213032-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11
A213032-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11
A213032-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213032-001	AB
A213032-002	AB
A213032-003	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 3 · 111 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
2026-02-19 14:30 UTC	2026-02	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213032-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213032-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213032-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-06-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213032-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213032-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213032-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213032-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213032-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213032-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213032-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213032-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213032-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213032-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213032-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213032-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213032-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213032-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213032-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213032-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213032-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213032-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213032-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213032-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213032-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213032-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213032-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213032-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213032-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213032-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213032-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213032-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213032-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213032-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213032-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213032-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213032-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213032-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213032-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213032-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213032-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213032-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213032-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213032-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILDENAFIL CITRATE	100 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312950	Internal RxNorm lookup
314228	Internal RxNorm lookup
314229	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
4c57d855-3b49-fe6e-e063-6294a90a5cd5	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
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
72303-0847-1	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
72303-0847-2	Sildenafil	100 in 1 BOTTLE	TABLET, FILM COATED	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72303-0847-1	EA - Each	72303-0847	42ef201b-084f-43eb-ad21-f1b34ed8a055	1	2026-05-22

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	HEC Pharm USA Inc.	4c57d855-3b49-fe6e-e063-6294a90a5cd5	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213032 application number: ANDA213032 ndc (product): 72303-0847

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
314229	sildenafil citrate 100 MG Oral Tablet	PSN	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
314228	sildenafil citrate 25 MG Oral Tablet	PSN	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
312950	sildenafil citrate 50 MG Oral Tablet	PSN	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
314229	sildenafil 100 MG Oral Tablet	SCD	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
314228	sildenafil 25 MG Oral Tablet	SCD	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
312950	sildenafil 50 MG Oral Tablet	SCD	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	4c57d855-3b49-fe6e-e063-6294a90a5cd5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72303-0847-1	72303084701	30 TABLET, FILM COATED in 1 BOTTLE (72303-0847-1)	2020-06-11	No	No	Current
72303-0847-2	72303084702	100 in 1 BOTTLE				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sildenafil	HEC Pharm USA Inc. \| Sunshine Lake Pharma Co., Ltd. \| MSN Organics Private Limited.	2026-03-06	HUMAN PRESCRIPTION DRUG LABEL	1