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 01:04:51

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
0378-5504-01	EA - Each	0378-5504	05ef8b82-e732-4812-85d0-7a6b541be13a	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0378-5504	0378-5504-01

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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078881-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05
A078881-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05
A078881-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05
A078881-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05
A078881-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05
A078881-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05
A078881-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19

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 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078881-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078881-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078881-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078881-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078881-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078881-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078881-007	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078881-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078881-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078881-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078881-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078881-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078881-006	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078881-007	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078881-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078881-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078881-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078881-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078881-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078881-006	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078881-007	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078881-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078881-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078881-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078881-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078881-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078881-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078881-007	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078881-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078881-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078881-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078881-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078881-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078881-006	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078881-007	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078881-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078881-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078881-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078881-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078881-005	AB	1	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

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