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 01:33:53

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
0078-0560-15	EA - Each	0078-0560	3cb2d03c-6660-45d3-8ae2-59f0d71cbcf3	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0078-0560	0078-0560-15

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 45.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022314-001	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-002	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-003	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-004	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-005	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N022314-001	AB
N022314-002	AB
N022314-003	AB
N022314-004	AB
N022314-005	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 6 · 225 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
2026-11-14 07:37:17	2026-10	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 225 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	N022314-001	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-002	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-003	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-004	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N022314-005	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N022314-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022314-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022314-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022314-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-005	AB	1	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-001	8101599	2023-05-16	Drug product	2012-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-001	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-001	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-002	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-002	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-002	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-003	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-003	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-003	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-004	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-004	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-004	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-005	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-005	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-005	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022314-001	8101599	2023-05-16	Drug product	2012-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-001	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-001	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-002	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-002	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-002	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-003	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-003	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-003	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-004	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-004	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-004	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-005	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-005	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-005	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022314-001	8101599	2023-05-16	Drug product	2012-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-001	8475839	2023-05-16	Drug product	2013-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-001	8475839*PED	2023-11-16	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-002	8101599	2023-05-16	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-002	8475839	2023-05-16	Drug product	2013-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-002	8475839*PED	2023-11-16	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-003	8101599	2023-05-16	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-003	8475839	2023-05-16	Drug product	2013-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-003	8475839*PED	2023-11-16	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-004	8101599	2023-05-16	Drug product		`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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