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 02:03:26

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
0078-0359-06	EA - Each	0078-0359	73ca538b-527a-4cbb-9a67-40897d4cb457	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0078-0359	0078-0359-06

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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021283-001	DIOVAN	VALSARTAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-002	DIOVAN	VALSARTAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-003	DIOVAN	VALSARTAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18
N021283-004	DIOVAN	VALSARTAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021283-001	AB
N021283-002	AB
N021283-003	AB
N021283-004	AB

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 5 · 172 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
2026-09-14 22:38:34	2026-08	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021283-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021283-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021283-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021283-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021283-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021283-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	AB	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	NPP	2024-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	NPP	2024-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	NPP	2024-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021283-001	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-002	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-004	NPP	2024-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-001	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-002	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-004	NPP	2024-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-001	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-002	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-004	NPP	2024-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-001	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-002	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-004	NPP	2024-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021283-001	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-002	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-004	NPP	2024-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-001	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-002	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-004	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021283-001	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-002	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-004	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021283-001	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-002	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-004	NPP	2024-04-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021283-001	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-002	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-004	NPP	2024-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021283-001	NPP	2024-04-19	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

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