Apretude

Product NDC: 49702-280
11-digit product format: 497020280
Labeler code: 49702
Product ID: 49702-280_cedc4b34-5c83-4d5f-a47f-7d5e93f71459
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cabotegravir
Dosage form: KIT
Labeler: ViiV Healthcare Company
Application: NDA215499
Marketing category: NDA
Marketing start: 2024-03-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215499-001	APRETUDE	CABOTEGRAVIR	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2021-12-20

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14
N215499-001	8410103	2031-02-04	Drug substance, Drug product	2022-01-14
N215499-001	11224597	2031-09-15	Drug product	2022-02-10
N215499-001	12138264	2031-09-15	Drug product	2024-12-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215499-001	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.

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	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215499-001	APRETUDE	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-12-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215499-001	8410103	2031-02-04	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215499-001	12138264	2031-09-15	Drug product	2024-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215499-001	8410103	2031-02-04	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215499-001	12138264	2031-09-15	Drug product	2024-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215499-001	12138264	2031-09-15	Drug product	2024-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215499-001	12138264	2031-09-15	Drug product	2024-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215499-001	12138264	2031-09-15	Drug product	2024-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215499-001	12138264	2031-09-15	Drug product	2024-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215499-001	12138264	2031-09-15	Drug product	2024-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215499-001	10927129	2026-04-28	Drug substance, Drug product	2022-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215499-001	8410103	2026-04-28	Drug substance, Drug product	2022-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215499-001	11224597	2031-09-15	Drug product	2022-02-10	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215499-001	NCE	2026-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215499-001	NCE	2026-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215499-001	NCE	2026-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215499-001	NCE	2026-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215499-001	NCE	2026-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215499-001	NCE	2026-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215499-001	NCE	2026-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215499-001	NCE	2026-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215499-001	NCE	2026-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215499-001	NCE	2026-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215499-001	NCE	2026-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215499-001	NCE	2026-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215499-001	NCE	2026-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215499-001	NCE	2026-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215499-001	NCE	2026-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215499-001	NCE	2026-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215499-001	NCE	2026-01-21	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215499-001	NCE	2026-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215499-001	NCE	2026-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215499-001	NCE	2026-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215499-001	NCE	2026-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215499-001	NCE	2026-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215499-001	NCE	2026-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215499-001	NCE	2026-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215499-001	NCE	2026-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215499-001	NCE	2026-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215499-001	NCE	2026-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215499-001	NCE	2026-01-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215499-001	NCE	2026-01-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215499-001	NCE	2026-01-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215499-001	NCE	2026-01-21	`a50c72e98297…`

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2588077	Internal RxNorm lookup
2588080	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
4338428e-43d4-4e02-ac9d-bd98e738a7da	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
49702-238-61	Apretude	3 mL in 1 VIAL	INJECTION, SUSPENSION, EXTENDED	3 mL	200 mg in 1mL	8
49702-280-63	Apretude	1 in 1 CARTON	KIT	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49702-280-63	ML - Milliliter	49702-280	3c50722f-cba5-48ea-a9d3-7bb4fd19100e	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49702-280	APRETUDE (CABOTEGRAVIR) KIT [VIIV HEALTHCARE COMPANY]	8	Current NDC, 2 package rows	20250419_4338428e-43d4-4e02-ac9d-bd98e738a7da.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
Apretude	CABOTEGRAVIR	ViiV Healthcare Company	4338428e-43d4-4e02-ac9d-bd98e738a7da	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215499 application number: NDA215499 ndc (product): 49702-280

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HMH0132Z1Q	CABOTEGRAVIR	1051375-10-0	Cabotegravir

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2588080	Apretude 600 MG in 3 ML Extended Release Injection	PSN	4338428e-43d4-4e02-ac9d-bd98e738a7da	8
2588077	cabotegravir 600 MG in 3 ML Extended Release Injection	PSN	4338428e-43d4-4e02-ac9d-bd98e738a7da	8
2588080	3 ML cabotegravir 200 MG/ML Injection [Apretude]	SBD	4338428e-43d4-4e02-ac9d-bd98e738a7da	8
2588077	3 ML cabotegravir 200 MG/ML Injection	SCD	4338428e-43d4-4e02-ac9d-bd98e738a7da	8
2588080	Apretude 200 MG/ML per 3 ML Injection	SY	4338428e-43d4-4e02-ac9d-bd98e738a7da	8
2588080	Apretude 600 MG per 3 ML Injection	SY	4338428e-43d4-4e02-ac9d-bd98e738a7da	8
2588077	cabotegravir 600 MG per 3 ML Injection	SY	4338428e-43d4-4e02-ac9d-bd98e738a7da	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49702-238-61	49702023861	3 mL in 1 VIAL	3 ml				Historical
49702-280-63	49702028063	1 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61)	1 kit	2024-03-31	Yes	No	Current