PREVYMIS

Product NDC: 0006-3076
11-digit product format: 000063076
Labeler code: 0006
Product ID: 0006-3076_282d792e-e2f2-4744-8526-4d18427c55cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LETERMOVIR
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA209939
Marketing category: NDA
Marketing start: 2017-11-08
Substance: LETERMOVIR
Active strength: 480 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209939-001	PREVYMIS	LETERMOVIR	240MG	TABLET / ORAL		RLD	2017-11-08
N209939-002	PREVYMIS	LETERMOVIR	480MG	TABLET / ORAL		RLD, RS	2017-11-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209939-001	RE46791	2029-01-18		Drug substance, Drug product	2020-04-21
N209939-002	RE46791	2029-01-18		Drug substance, Drug product	2020-04-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209939-001	I-916	2026-06-05
N209939-001	D-189	2026-08-02
N209939-001	NPP	2027-08-30
N209939-001	ODE-423	2030-06-05
N209939-001	ODE-495	2031-08-30
N209939-001	ODE-497	2031-08-30
N209939-002	I-916	2026-06-05
N209939-002	D-189	2026-08-02
N209939-002	NPP	2027-08-30
N209939-002	ODE-423	2030-06-05
N209939-002	ODE-495	2031-08-30
N209939-002	ODE-497	2031-08-30

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209939-001	PREVYMIS	240MG	TABLET / ORAL	RLD	2017-11-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209939-002	PREVYMIS	480MG	TABLET / ORAL	RLD, RS	2017-11-08	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 154 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209939-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209939-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209939-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209939-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209939-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209939-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209939-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209939-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209939-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209939-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209939-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209939-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209939-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209939-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209939-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209939-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-21	`301d65b070ca…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N209939-001	I-916	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-001	D-189	2026-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-001	NPP	2027-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-001	ODE-423	2030-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-001	ODE-495	2031-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-001	ODE-497	2031-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	I-916	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	D-189	2026-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	NPP	2027-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	ODE-423	2030-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	ODE-495	2031-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209939-002	ODE-497	2031-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209939-001	I-916	2026-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-001	D-189	2026-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-001	NPP	2027-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-001	ODE-423	2030-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-001	ODE-495	2031-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-001	ODE-497	2031-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	I-916	2026-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	D-189	2026-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	NPP	2027-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	ODE-423	2030-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	ODE-495	2031-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209939-002	ODE-497	2031-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	I-916	2026-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	D-189	2026-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	NPP	2027-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	ODE-423	2030-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	ODE-495	2031-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-001	ODE-497	2031-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	I-916	2026-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	D-189	2026-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	NPP	2027-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	ODE-423	2030-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	ODE-495	2031-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209939-002	ODE-497	2031-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209939-001	I-916	2026-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209939-001	D-189	2026-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209939-001	NPP	2027-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209939-001	ODE-423	2030-06-05	`6a471c1ec25d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LETERMOVIR	480 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1H09Y5WO1F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1988652	Internal RxNorm lookup
1988657	Internal RxNorm lookup
1988660	Internal RxNorm lookup
1988661	Internal RxNorm lookup
1988666	Internal RxNorm lookup
1988671	Internal RxNorm lookup
1988673	Internal RxNorm lookup
1988675	Internal RxNorm lookup
2693185	Internal RxNorm lookup
2693189	Internal RxNorm lookup
2693191	Internal RxNorm lookup
2693193	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
1b49df80-be4f-47e0-a0b7-123f3e69395b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33e56060-0089-4cc9-bb16-d2fc207d0bfd	Product name	2	20250318
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0006-3076-01	PREVYMIS	7 in 1 DOSE PACK	TABLET, FILM COATED	7	28
0006-3076-02	PREVYMIS	4 in 1 CARTON	TABLET, FILM COATED	4	28
0006-3076-03	PREVYMIS	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	28
0006-3076-04	PREVYMIS	14 in 1 CARTON	TABLET, FILM COATED	14	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-3076-01	EA - Each	0006-3076	9db5294a-063e-4a9e-9afc-79ba563b3ee1	1	2018-03-08
0006-3076-02	EA - Each	0006-3076	22c72308-37ef-42e4-9ffa-0a9bd7eb8849	1	2018-01-12
0006-3076-03	EA - Each	0006-3076	72b3c957-f2db-4dac-8010-ca5a4011c639	1	2018-04-19
0006-3076-04	EA - Each	0006-3076	47ffe391-848b-417d-89d6-8f243e90cc48	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-3076	PREVYMIS (LETERMOVIR) TABLET, FILM COATED PREVYMIS (LETERMOVIR) INJECTION, SOLUTION PREVYMIS (LETERMOVIR) PELLET [MERCK SHARP & DOHME LLC]	27	Current NDC, Legacy NDC, 4 package rows	20250215_1b49df80-be4f-47e0-a0b7-123f3e69395b.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
PREVYMIS	LETERMOVIR	Merck Sharp & Dohme LLC	1b49df80-be4f-47e0-a0b7-123f3e69395b	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209939 application number: NDA209939 ndc (product): 0006-3076

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1H09Y5WO1F	LETERMOVIR	917389-32-3	LETERMOVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2693191	letermovir 120 MG Oral Pellet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693185	letermovir 20 MG Oral Pellet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988652	letermovir 240 MG in 12 ML Injection	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988666	letermovir 240 MG Oral Tablet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988660	letermovir 480 MG in 24 ML Injection	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988673	letermovir 480 MG Oral Tablet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693193	PREVYMIS 120 MG Oral Pellet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693189	PREVYMIS 20 MG Oral Pellet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988657	PREVYMIS 240 MG in 12 ML Injection	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988671	PREVYMIS 240 MG Oral Tablet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988661	Prevymis 480 MG in 24 ML Injection	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988675	PREVYMIS 480 MG Oral Tablet	PSN	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988657	12 ML letermovir 20 MG/ML Injection [Prevymis]	SBD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988661	24 ML letermovir 20 MG/ML Injection [Prevymis]	SBD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693193	letermovir 120 MG Oral Pellet [Prevymis]	SBD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693189	letermovir 20 MG Oral Pellet [Prevymis]	SBD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988671	letermovir 240 MG Oral Tablet [Prevymis]	SBD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988675	letermovir 480 MG Oral Tablet [Prevymis]	SBD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988652	12 ML letermovir 20 MG/ML Injection	SCD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988660	24 ML letermovir 20 MG/ML Injection	SCD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693191	letermovir 120 MG Oral Pellet	SCD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693185	letermovir 20 MG Oral Pellet	SCD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988666	letermovir 240 MG Oral Tablet	SCD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988673	letermovir 480 MG Oral Tablet	SCD	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988652	letermovir 20 MG/ML per 12 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988660	letermovir 20 MG/ML per 24 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988652	letermovir 240 MG per 12 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988660	letermovir 480 MG per 24 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693193	Prevymis 120 MG Oral Pellet	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
2693189	Prevymis 20 MG Oral Pellet	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988657	Prevymis 20 MG/ML per 12 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988661	Prevymis 20 MG/ML per 24 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988671	Prevymis 240 MG Oral Tablet	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988657	Prevymis 240 MG per 12 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988675	Prevymis 480 MG Oral Tablet	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28
1988661	Prevymis 480 MG per 24 ML Injection	SY	1b49df80-be4f-47e0-a0b7-123f3e69395b	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-3076-01	00006307601	7 in 1 DOSE PACK						Historical
0006-3076-02	00006307602	4 DOSE PACK in 1 CARTON (0006-3076-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3076-01)	4 dose pack	2017-11-08	0000-00-00	No	No	Current
0006-3076-03	00006307603	1 in 1 BLISTER PACK						Historical
0006-3076-04	00006307604	14 BLISTER PACK in 1 CARTON (0006-3076-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-3076-03)	14 blister pack	2017-11-08	0000-00-00	No	No	Current