National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 01:25:01

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-0227-61	EA - Each	0006-0227	2afec18e-a0c8-4fc1-95a7-eaf2b3771e9b	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0006-0227	0006-0227-61

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N022145-001	ISENTRESS	RALTEGRAVIR POTASSIUM	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12
N022145-002	ISENTRESS HD	RALTEGRAVIR POTASSIUM	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022145-001	AB
N022145-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27
N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product
N022145-001	7754731*PED	2029-09-11		Pediatric extension
N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27
N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23
N022145-002	7754731*PED	2029-09-11		Pediatric extension
N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27
N022145-002	9649311	2030-10-21		Drug product	2017-06-23
N022145-002	9649311*PED	2031-04-21		Pediatric extension
N022145-002	10772888	2032-03-30	U-1663		2020-10-27

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL	AB	RLD, RS	2017-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL	AB	RLD, RS	2007-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022145-001	ISENTRESS	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2007-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022145-002	ISENTRESS HD	EQ 600MG BASE	TABLET / ORAL		RLD, RS	2017-05-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022145-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022145-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022145-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022145-002	AB	1	`6a471c1ec25d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022145-001	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022145-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 704 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022145-001	8852632	2028-01-28	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	7754731	2029-03-11	U-257	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-001	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	7754731	2029-03-11	U-257	Drug substance, Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	7754731*PED	2029-09-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	8771733	2030-06-02	U-257	Drug substance, Drug product	2023-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	9649311	2030-10-21		Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	9649311*PED	2031-04-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022145-002	10772888	2032-03-30	U-1663		2020-10-27	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022145-001	D-167	2020-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	PED	2020-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-001	PED	2021-05-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	NS	2020-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	NPP	2020-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	PED	2020-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022145-002	PED	2021-05-22	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022145-001	PED	2021-05-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022145-002	PED	2021-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022145-001	PED	2021-05-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022145-002	PED	2021-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022145-001	PED	2021-05-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022145-002	PED	2021-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022145-001	D-167	2020-05-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	PED	2020-11-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-001	PED	2021-05-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	NS	2020-05-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	NPP	2020-11-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	PED	2020-11-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022145-002	PED	2021-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022145-001	D-167	2020-05-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	PED	2020-11-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-001	PED	2021-05-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	NS	2020-05-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	NPP	2020-11-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	PED	2020-11-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022145-002	PED	2021-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022145-001	D-167	2020-05-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	PED	2020-11-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-001	PED	2021-05-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	NS	2020-05-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	NPP	2020-11-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	PED	2020-11-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022145-002	PED	2021-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022145-001	D-167	2020-05-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022145-001	NPP	2020-11-22	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.