EDURANT PED

Product NDC: 59676-280
11-digit product format: 596760280
Labeler code: 59676
Product ID: 59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rilpivirine hydrochloride
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Janssen Products, LP
Application: NDA219016
Marketing category: NDA
Marketing start: 2024-03-15
Substance: RILPIVIRINE HYDROCHLORIDE
Active strength: 2.5 mg/1
Pharmacologic classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N219016-001	EDURANT PED	RILPIVIRINE HYDROCHLORIDE	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2024-03-15

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219016-001	11065198	2037-10-23		Drug product	2024-05-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219016-001	NP	2027-03-15
N219016-001	PED	2027-09-15

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD	2024-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD	2024-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD	2024-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD	2024-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD	2024-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD	2024-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD	2024-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219016-001	EDURANT PED	EQ 2.5MG BASE	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2024-03-15	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N219016-001	7125879	2025-04-21	U-3874	Drug substance, Drug product	2024-04-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219016-001	11065198	2037-10-23		Drug product	2024-05-02	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N219016-001	NP	2027-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219016-001	PED	2027-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219016-001	NP	2027-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219016-001	PED	2027-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219016-001	NP	2027-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219016-001	PED	2027-09-15	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219016-001	NP	2027-03-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219016-001	PED	2027-09-15	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: EDURANT PED
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RILPIVIRINE HYDROCHLORIDE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
212WAX8KDD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1102273	Internal RxNorm lookup
1102277	Internal RxNorm lookup
2678244	Internal RxNorm lookup
2678248	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
03880372-2c68-45c6-a53a-f420c49541d6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33cd1557-9629-1a35-1f2f-499cf7c608bc	Product name	2	20260305
38d19fab-47e8-d825-5329-4948eaa6d686	Product name	2	20250124
f306ec07-0d7d-45ce-ade0-e6c8659560b1	Product name	1	20210621
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
44633898-5724-4273-abcc-3541a1107946	Product name	1	20180124
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59676-280-01	EDURANT PED	10 in 1 BLISTER PACK	TABLET, FOR SUSPENSION	10		28
59676-280-90	EDURANT PED	9 in 1 CARTON	TABLET, FOR SUSPENSION	9		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-280-01	EA - Each	59676-280	d0a0ff69-020d-448d-97ab-4cf4f0e552ba	1	2025-06-13
59676-280-90	EA - Each	59676-280	b4be1cfb-bc46-4882-beac-cc479e2757cc	1	2025-06-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
rilpivirine hydrochloride	ACTIVE INGREDIENT	212WAX8KDD	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
rilpivirine	ACTIVE MOIETY	FI96A8X663	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59676-280	EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED EDURANT PED (RILPIVIRINE HYDROCHLORIDE) TABLET, FOR SUSPENSION [JANSSEN PRODUCTS, LP]	27	Current NDC, 2 package rows	20250210_03880372-2c68-45c6-a53a-f420c49541d6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EDURANT	RILPIVIRINE HYDROCHLORIDE	Janssen Products, LP	03880372-2c68-45c6-a53a-f420c49541d6	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219016 application number: NDA219016 ndc (product): 59676-280

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
212WAX8KDD	RILPIVIRINE HYDROCHLORIDE	700361-47-3	RILPIVIRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2678248	EDURANT 2.5 MG Tablet for Oral Suspension	PSN	03880372-2c68-45c6-a53a-f420c49541d6	28
1102277	EDURANT 25 MG Oral Tablet	PSN	03880372-2c68-45c6-a53a-f420c49541d6	28
2678244	rilpivirine 2.5 MG Tablet for Oral Suspension	PSN	03880372-2c68-45c6-a53a-f420c49541d6	28
1102273	rilpivirine 25 MG Oral Tablet	PSN	03880372-2c68-45c6-a53a-f420c49541d6	28
2678248	rilpivirine 2.5 MG Tablet for Oral Suspension [Edurant]	SBD	03880372-2c68-45c6-a53a-f420c49541d6	28
1102277	rilpivirine 25 MG Oral Tablet [Edurant]	SBD	03880372-2c68-45c6-a53a-f420c49541d6	28
2678244	rilpivirine 2.5 MG Tablet for Oral Suspension	SCD	03880372-2c68-45c6-a53a-f420c49541d6	28
1102273	rilpivirine 25 MG Oral Tablet	SCD	03880372-2c68-45c6-a53a-f420c49541d6	28
2678248	Edurant 2.5 MG (rilpivirine hydrochloride 2.75 MG) Tablet for Oral Suspension	SY	03880372-2c68-45c6-a53a-f420c49541d6	28
2678248	Edurant 2.5 MG Tablet for Oral Suspension	SY	03880372-2c68-45c6-a53a-f420c49541d6	28
1102277	Edurant 25 MG (rilpivirine hydrochloride 27.5 MG) Oral Tablet	SY	03880372-2c68-45c6-a53a-f420c49541d6	28
1102277	Edurant 25 MG Oral Tablet	SY	03880372-2c68-45c6-a53a-f420c49541d6	28
2678244	rilpivirine 2.5 MG (rilpivirine hydrochloride 2.75 MG) Tablet for Oral Suspension	SY	03880372-2c68-45c6-a53a-f420c49541d6	28
1102273	rilpivirine 25 MG (rilpivirine hydrochloride 27.5 MG) Oral Tablet	SY	03880372-2c68-45c6-a53a-f420c49541d6	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59676-280-01	59676028001	10 in 1 BLISTER PACK					Historical
59676-280-90	59676028090	9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)	9 blister pack	2024-03-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EDURANT	Janssen Products, LP \| AndersonBrecon Inc \| Janssen Pharmaceutica NV \| Janssen-Cilag SpA \| Johnson & Johnson Private Limited \| Janssen Pharmaceutical Sciences Unlimited Company	2025-08-28	HUMAN PRESCRIPTION DRUG LABEL	28