Stendra

Product NDC: 72384-752
Requested package NDC: 72384-752-99
11-digit product format: 723840752
Labeler code: 72384
Product ID: 72384-752_02c03667-4518-4b43-ae10-f915132a0224
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: avanafil
Dosage form: TABLET
Route: ORAL
Labeler: Metuchen Pharmaceuticals, LLC
Application: NDA202276
Marketing category: NDA
Marketing start: 2013-12-27
Marketing end: 0000-00-00
Substance: AVANAFIL
Active strength: 100 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	72384-752	72384-752-99	I	Inactivated by FDA		2026-09-14

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	RLD / RS	Approval date
N202276-001	STENDRA	AVANAFIL	50MG	TABLET / ORAL	AB	RLD	2012-04-27
N202276-002	STENDRA	AVANAFIL	100MG	TABLET / ORAL	AB	RLD	2012-04-27
N202276-003	STENDRA	AVANAFIL	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202276-001	AB
N202276-002	AB
N202276-003	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	STENDRA	100MG	TABLET / ORAL	AB	RLD	2012-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	STENDRA	200MG	TABLET / ORAL	AB	RLD, RS	2012-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	STENDRA	50MG	TABLET / ORAL	AB	RLD	2012-04-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	N202276-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202276-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202276-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202276-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202276-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202276-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	AB	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 189 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202276-001	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-002	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-003	6656935	2025-04-27	U-155	Drug substance, Drug product	2012-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202276-001	7501409	2023-05-05		Drug product		`5c6f7cd8ea54…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-001	M-282	2025-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-002	M-282	2025-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202276-003	M-282	2025-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202276-001	M-282	2025-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-002	M-282	2025-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202276-003	M-282	2025-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-001	M-282	2025-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-002	M-282	2025-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202276-003	M-282	2025-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-001	M-282	2025-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-002	M-282	2025-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202276-003	M-282	2025-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-001	M-282	2025-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-002	M-282	2025-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202276-003	M-282	2025-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-001	M-282	2025-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-002	M-282	2025-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202276-003	M-282	2025-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-001	M-282	2025-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-002	M-282	2025-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202276-003	M-282	2025-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-001	M-282	2025-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-002	M-282	2025-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202276-003	M-282	2025-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202276-001	M-282	2025-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-002	M-282	2025-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202276-003	M-282	2025-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-001	M-282	2025-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-002	M-282	2025-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202276-003	M-282	2025-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-001	M-282	2025-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-002	M-282	2025-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202276-003	M-282	2025-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-001	M-282	2025-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-002	M-282	2025-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202276-003	M-282	2025-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202276-001	M-282	2025-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-002	M-282	2025-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202276-003	M-282	2025-10-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202276-001	M-282	2025-10-18	`6a51e52b5d6a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
243aee53-eae8-56a8-2c9a-3e2b54bd0684	Product name	2	20250225

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
72384-752-30	2026-01-29	These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
72384-752-99	2026-01-29	These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
72384-752-30	2024-01-30	These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
72384-752-99	2024-01-30	These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72384-752-01	Stendra	1 in 1 BLISTER PACK	TABLET	1	7
72384-752-30	Stendra	30 in 1 BOTTLE	TABLET	30	7
72384-752-99	Stendra	6 in 1 CARTON	TABLET	6	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72384-752-30	EA - Each	72384-752	c370e575-434d-4332-8d7e-38ed73977cf0	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72384-752	STENDRA (AVANAFIL) TABLET [METUCHEN PHARMACEUTICALS, LLC]	7	Legacy NDC, 3 package rows	20240724_fa7d93e3-b69b-4e02-8146-89760cd8e9d6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DR5S136IVO	AVANAFIL	330784-47-9	AVANAFIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1291306	avanafil 100 MG Oral Tablet	PSN	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291365	avanafil 200 MG Oral Tablet	PSN	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291369	avanafil 50 MG Oral Tablet	PSN	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291312	Stendra 100 MG Oral Tablet	PSN	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291367	Stendra 200 MG Oral Tablet	PSN	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291371	Stendra 50 MG Oral Tablet	PSN	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291312	avanafil 100 MG Oral Tablet [Stendra]	SBD	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291367	avanafil 200 MG Oral Tablet [Stendra]	SBD	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291371	avanafil 50 MG Oral Tablet [Stendra]	SBD	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291306	avanafil 100 MG Oral Tablet	SCD	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291365	avanafil 200 MG Oral Tablet	SCD	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291369	avanafil 50 MG Oral Tablet	SCD	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291312	Stendra 100 MG Oral Tablet	SY	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291367	Stendra 200 MG Oral Tablet	SY	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7
1291371	Stendra 50 MG Oral Tablet	SY	fa7d93e3-b69b-4e02-8146-89760cd8e9d6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72384-752-99	72384075299	6 BLISTER PACK in 1 CARTON (72384-752-99) > 1 TABLET in 1 BLISTER PACK (72384-752-01)	6 blister pack	2020-08-10	0000-00-00	Yes	No	Current