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 02:37:22

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
64679-787-02	EA - Each	64679-787	c356a781-e82e-41ae-9d58-4db7ec95f81b	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64679-787	64679-787-02

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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021485-001	STALEVO 50	CARBIDOPA; ENTACAPONE; LEVODOPA	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11
N021485-002	STALEVO 100	CARBIDOPA; ENTACAPONE; LEVODOPA	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11
N021485-003	STALEVO 150	CARBIDOPA; ENTACAPONE; LEVODOPA	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11
N021485-004	STALEVO 200	CARBIDOPA; ENTACAPONE; LEVODOPA	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02
N021485-005	STALEVO 75	CARBIDOPA; ENTACAPONE; LEVODOPA	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29
N021485-006	STALEVO 125	CARBIDOPA; ENTACAPONE; LEVODOPA	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021485-001	AB
N021485-002	AB
N021485-003	AB
N021485-004	AB
N021485-005	AB
N021485-006	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 7 · 258 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	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 226 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	N021485-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021485-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021485-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021485-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021485-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-004	AB	1	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021485-001	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-001	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-002	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-002	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-003	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-003	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-004	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-004	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-005	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-005	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-006	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-006	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021485-001	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-001	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-002	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-002	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-003	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-003	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-004	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-004	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-005	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-005	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-006	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-006	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021485-001	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-001	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-002	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-002	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-003	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-003	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-004	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-004	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-005	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-005	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-006	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-006	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021485-001	6500867	2020-06-29	U-219	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021485-001	6797732	2020-06-29		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021485-002	6500867	2020-06-29	U-219	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021485-002	6797732	2020-06-29		Drug product	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

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