Cabenuva

Product NDC: 49702-253
11-digit product format: 497020253
Labeler code: 49702
Product ID: 49702-253_15253b2a-c96c-489c-be6d-b37fcb63ad5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cabotegravir and rilpivirine
Dosage form: KIT
Labeler: ViiV Healthcare Company
Application: NDA212888
Marketing category: NDA
Marketing start: 2021-01-21
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212888-001	CABENUVA KIT	CABOTEGRAVIR; RILPIVIRINE	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2021-01-21
N212888-002	CABENUVA KIT	CABOTEGRAVIR; RILPIVIRINE	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2021-01-21

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22
N212888-001	11389447	2027-06-30	U-3405		2022-08-17
N212888-001	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16
N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15
N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05
N212888-001	RE50189	2031-11-27	U-3348		2024-12-16
N212888-001	11389448	2032-04-13		Drug product	2025-04-30
N212888-001	12178815	2038-07-18	U-3348		2025-01-13
N212888-001	12636285	2040-10-01	U-3348		2026-06-10
N212888-001	12636286	2040-10-01	U-3348		2026-06-10
N212888-002	10927129	2026-04-28		Drug substance, Drug product	2021-03-22
N212888-002	11389447	2027-06-30	U-3405		2022-08-17
N212888-002	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16
N212888-002	11224597	2031-09-15	U-3348	Drug product	2022-02-15
N212888-002	12138264	2031-09-15	U-3348	Drug product	2024-12-05
N212888-002	RE50189	2031-11-27	U-3348		2024-12-16
N212888-002	11389448	2032-04-13		Drug product	2025-04-30
N212888-002	12178815	2038-07-18	U-3348		2025-01-13
N212888-002	12636285	2040-10-01	U-3348		2026-06-10
N212888-002	12636286	2040-10-01	U-3348		2026-06-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212888-001	NCE	2026-01-21
N212888-002	NCE	2026-01-21

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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212888-001	CABENUVA KIT	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212888-002	CABENUVA KIT	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-01-21	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 408 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	11389447	2027-06-30	U-3405		2022-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	RE50189	2031-11-27	U-3348		2024-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	11389448	2032-04-13		Drug product	2025-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-001	12178815	2038-07-18	U-3348		2025-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	11389447	2027-06-30	U-3405		2022-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	RE50189	2031-11-27	U-3348		2024-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	11389448	2032-04-13		Drug product	2025-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	12178815	2038-07-18	U-3348		2025-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	7125879	2025-04-21	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	11389447	2027-06-30	U-3405		2022-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	RE50189	2031-11-27	U-3348		2024-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	11389448	2032-04-13		Drug product	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	12178815	2038-07-18	U-3348		2025-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	7125879	2025-04-21	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	11389447	2027-06-30	U-3405		2022-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	8410103	2031-02-04	U-3348	Drug substance, Drug product	2021-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	RE50189	2031-11-27	U-3348		2024-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	11389448	2032-04-13		Drug product	2025-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	12178815	2038-07-18	U-3348		2025-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212888-001	7125879	2025-04-21	U-3348	Drug substance, Drug product	2021-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	10927129	2026-04-28		Drug substance, Drug product	2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	8410103	2026-04-28	U-3348	Drug substance, Drug product	2021-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	11389447	2027-06-30	U-3405		2022-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	11224597	2031-09-15	U-3348	Drug product	2022-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	12138264	2031-09-15	U-3348	Drug product	2024-12-05	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 178 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212888-001	NCE	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212888-002	NCE	2026-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	D-184	2025-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	NPP	2025-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-001	NCE	2026-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	D-184	2025-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	NPP	2025-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212888-002	NCE	2026-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212888-001	D-184	2025-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	NPP	2025-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-001	NCE	2026-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	D-184	2025-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	NPP	2025-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212888-002	NCE	2026-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	D-184	2025-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	NPP	2025-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-001	NCE	2026-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	D-184	2025-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	NPP	2025-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212888-002	NCE	2026-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	D-184	2025-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	NPP	2025-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-001	NCE	2026-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	D-184	2025-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	NPP	2025-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212888-002	NCE	2026-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	D-184	2025-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	NPP	2025-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-001	NCE	2026-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	D-184	2025-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	NPP	2025-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212888-002	NCE	2026-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	D-184	2025-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	NPP	2025-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-001	NCE	2026-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	D-184	2025-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	NPP	2025-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212888-002	NCE	2026-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-001	D-184	2025-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212888-001	NPP	2025-03-29	`5bbf6a4d5a75…`

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2475415	Internal RxNorm lookup
2475416	Internal RxNorm lookup
2475417	Internal RxNorm lookup
2475418	Internal RxNorm lookup
2588077	Internal RxNorm lookup
2594978	Internal RxNorm lookup
2594980	Internal RxNorm lookup
2594982	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
1698baf3-f895-4c42-a1b1-e9ee3f20da36	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
38d19fab-47e8-d825-5329-4948eaa6d686	Product name	2	20250124
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
ba89f589-ed67-48fe-9931-d0915055348a	Product name	1	20220728
f306ec07-0d7d-45ce-ade0-e6c8659560b1	Product name	1	20210621
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
dc78e92e-f760-407c-94a4-da4867af6b2b	Product name	1	20210204
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
44633898-5724-4273-abcc-3541a1107946	Product name	1	20180124
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49702-245-01	Cabenuva	2 mL in 1 VIAL	INJECTION, SUSPENSION, EXTENDED	1 mL	200 mg in 1mL	16
49702-249-02	Cabenuva	2 mL in 1 VIAL	INJECTION, SUSPENSION, EXTENDED	1 mL	300 mg in 1mL	16
49702-253-15	Cabenuva	1 in 1 CARTON	KIT	1		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49702-253-15	ML - Milliliter	49702-253	3105582b-c1c7-4f8a-8030-49abb2b1305e	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49702-253	CABENUVA (CABOTEGRAVIR AND RILPIVIRINE) KIT [VIIV HEALTHCARE COMPANY]	14	Current NDC, Legacy NDC, 3 package rows	20250416_1698baf3-f895-4c42-a1b1-e9ee3f20da36.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
Cabenuva	CABOTEGRAVIR AND RILPIVIRINE	ViiV Healthcare Company	1698baf3-f895-4c42-a1b1-e9ee3f20da36	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212888 application number: NDA212888 ndc (product): 49702-253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2475418	{1 (2 ML cabotegravir 200 MG/ML Injection) / 1 (2 ML rilpivirine 300 MG/ML Injection) } Pack [CABENUVA 400 MG / 600 MG]	BPCK	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475416	{1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } Pack [CABENUVA 600 MG / 900 MG]	BPCK	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475417	{1 (2 ML cabotegravir 200 MG/ML Injection) / 1 (2 ML rilpivirine 300 MG/ML Injection) } Pack	GPCK	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475415	{1 (3 ML cabotegravir 200 MG/ML Injection) / 1 (3 ML rilpivirine 300 MG/ML Injection) } Pack	GPCK	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475418	CABENUVA 400 MG / 600 MG Extended Release Kit	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475416	CABENUVA 600 MG / 900 MG Extended Release Kit	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475417	cabotegravir 400 MG / rilpivirine 600 MG Extended Release Kit	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594978	cabotegravir 400 MG in 2 ML Extended Release Injection	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475415	cabotegravir 600 MG / rilpivirine 900 MG Extended Release Kit	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2588077	cabotegravir 600 MG in 3 ML Extended Release Injection	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594982	rilpivirine 600 MG in 2 ML Extended Release Injection	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594980	rilpivirine 900 MG in 3 ML Extended Release Injection	PSN	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594978	2 ML cabotegravir 200 MG/ML Injection	SCD	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594982	2 ML rilpivirine 300 MG/ML Injection	SCD	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2588077	3 ML cabotegravir 200 MG/ML Injection	SCD	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594980	3 ML rilpivirine 300 MG/ML Injection	SCD	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475418	CABENUVA 400 MG / 600 MG Extended Release Kit	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475416	CABENUVA 600 MG / 900 MG Extended Release Kit	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475417	cabotegravir 400 MG / rilpivirine 600 MG Extended Release Kit	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594978	cabotegravir 400 MG per 2 ML Injection	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2475415	cabotegravir 600 MG / rilpivirine 900 MG Extended Release Kit	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2588077	cabotegravir 600 MG per 3 ML Injection	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594982	rilpivirine 600 MG per 2 ML Injection	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16
2594980	rilpivirine 900 MG per 3 ML Injection	SY	1698baf3-f895-4c42-a1b1-e9ee3f20da36	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49702-245-01	49702024501	2 mL in 1 VIAL	2 ml					Historical
49702-249-02	49702024902	2 mL in 1 VIAL	2 ml					Historical
49702-253-15	49702025315	1 KIT in 1 CARTON (49702-253-15) * 2 mL in 1 VIAL (49702-245-01) * 2 mL in 1 VIAL (49702-249-02)	1 kit	2021-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cabenuva	ViiV Healthcare Company \| Glaxo Wellcome Manufacturing Pte. Ltd \| Janssen Pharmaceutica NV	2025-11-26	HUMAN PRESCRIPTION DRUG LABEL	16