PIFELTRO

Product NDC: 50090-6268
11-digit product format: 500906268
Labeler code: 50090
Product ID: 50090-6268_82b1d205-8f81-4755-b34d-931352fa834b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doravirine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA210806
Marketing category: NDA
Marketing start: 2018-07-20
Substance: DORAVIRINE
Active strength: 100 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
N210806-001	PIFELTRO	DORAVIRINE	100MG	TABLET / ORAL		RLD, RS	2018-08-30

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17
N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17
N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17

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 · 42 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	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210806-001	PIFELTRO	100MG	TABLET / ORAL	RLD, RS	2018-08-30	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 114 observed states.

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	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210806-001	8486975	2032-08-30	U-2630	Drug substance, Drug product	2018-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210806-001	8486975	2032-08-30	U-2394	Drug substance, Drug product	2018-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210806-001	8486975	2032-08-30	U-3308	Drug substance, Drug product	2018-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210806-001	8486975	2031-10-07	U-2630	Drug substance, Drug product	2018-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210806-001	8486975	2031-10-07	U-2394	Drug substance, Drug product	2018-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210806-001	8486975	2031-10-07	U-3308	Drug substance, Drug product	2018-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210806-001	8486975	2031-10-07	U-2630	Drug substance, Drug product	2018-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210806-001	8486975	2031-10-07	U-2394	Drug substance, Drug product	2018-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210806-001	8486975	2031-10-07	U-3308	Drug substance, Drug product	2018-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210806-001	8486975	2031-10-07	U-2630	Drug substance, Drug product	2018-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210806-001	8486975	2031-10-07	U-2394	Drug substance, Drug product	2018-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210806-001	8486975	2031-10-07	U-3308	Drug substance, Drug product	2018-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210806-001	8486975	2031-10-07	U-2630	Drug substance, Drug product	2018-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210806-001	8486975	2031-10-07	U-2394	Drug substance, Drug product	2018-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210806-001	8486975	2031-10-07	U-3308	Drug substance, Drug product	2018-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210806-001	8486975	2031-10-07	U-2630	Drug substance, Drug product	2018-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210806-001	8486975	2031-10-07	U-2394	Drug substance, Drug product	2018-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210806-001	8486975	2031-10-07	U-3308	Drug substance, Drug product	2018-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210806-001	8486975	2031-10-07	U-2630	Drug substance, Drug product	2018-09-17	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 65 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	N210806-001	NPP	2025-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210806-001	NPP	2025-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210806-001	NPP	2025-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210806-001	NPP	2025-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210806-001	NPP	2025-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210806-001	NPP	2025-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210806-001	NPP	2025-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210806-001	NPP	2025-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210806-001	NPP	2025-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210806-001	NPP	2025-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210806-001	NPP	2025-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210806-001	NPP	2025-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210806-001	NPP	2025-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210806-001	I-827	2022-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210806-001	NCE	2023-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210806-001	NPP	2025-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210806-001	I-827	2022-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210806-001	NCE	2023-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210806-001	I-827	2022-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210806-001	NCE	2023-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210806-001	NCE	2023-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210806-001	I-827	2022-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210806-001	NCE	2023-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210806-001	I-827	2022-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210806-001	NCE	2023-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210806-001	I-827	2022-09-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210806-001	NCE	2023-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210806-001	I-827	2022-09-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210806-001	NCE	2023-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210806-001	I-827	2022-09-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210806-001	NCE	2023-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210806-001	I-827	2022-09-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210806-001	NCE	2023-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210806-001	NCE	2023-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210806-001	NCE	2023-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210806-001	NCE	2023-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210806-001	NPP	2025-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210806-001	NPP	2025-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210806-001	NCE	2023-08-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N210806-001	NPP	2025-01-27	`ea1830bbd6c7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DORAVIRINE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
913P6LK81M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2055760	Internal RxNorm lookup
2055766	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
ff06e5cc-f47a-4779-816b-0e5b13e88a25	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
96181e45-8c55-4690-9c33-4c540d16a217	Product name	1	20181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6268-0	PIFELTRO	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6268-0	EA - Each	50090-6268	174f25a6-1569-485e-a160-debbc0128632	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6268	PIFELTRO (DORAVIRINE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 1 package rows	20240103_ff06e5cc-f47a-4779-816b-0e5b13e88a25.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PIFELTRO	DORAVIRINE	A-S Medication Solutions	ff06e5cc-f47a-4779-816b-0e5b13e88a25	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210806 application number: NDA210806 ndc (product): 50090-6268
PIFELTRO	DORAVIRINE	Merck Sharp & Dohme LLC	76ce1f00-28c0-4314-bd2c-d473fe3d0970	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210806 application number: NDA210806

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
913P6LK81M	DORAVIRINE	1338225-97-0	DORAVIRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2055760	doravirine 100 MG Oral Tablet	PSN	ff06e5cc-f47a-4779-816b-0e5b13e88a25	3
2055766	Pifeltro 100 MG Oral Tablet	PSN	ff06e5cc-f47a-4779-816b-0e5b13e88a25	3
2055766	doravirine 100 MG Oral Tablet [Pifeltro]	SBD	ff06e5cc-f47a-4779-816b-0e5b13e88a25	3
2055760	doravirine 100 MG Oral Tablet	SCD	ff06e5cc-f47a-4779-816b-0e5b13e88a25	3
2055766	Pifeltro 100 MG Oral Tablet	SY	ff06e5cc-f47a-4779-816b-0e5b13e88a25	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6268-0	50090626800	30 TABLET, FILM COATED in 1 BOTTLE (50090-6268-0)	2022-12-13	0000-00-00	No	No	Current