Stalevo

Product NDC: 52427-809
11-digit product format: 524270809
Labeler code: 52427
Product ID: 52427-809_e400f8d7-39a0-1b94-222b-73dc9403ba4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa, levodopa, and entacapone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Almatica Pharma LLC
Application: NDA021485
Marketing category: NDA
Marketing start: 2020-10-05
Marketing end: 0000-00-00
Substance: CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength: 19 mg/1; mg/1; mg/1
Pharmacologic classes: Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52427-809		D	Discontinued by firm		2026-10-16
excluded package	package	52427-809	52427-809-01	D	Discontinued by firm		2026-10-16

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

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 · 264 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	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 6 · 232 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021485-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021485-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021485-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021485-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021485-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021485-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021485-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021485-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021485-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021485-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021485-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021485-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021485-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021485-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021485-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021485-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021485-005	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021485-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021485-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021485-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021485-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021485-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021485-005	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021485-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021485-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021485-002	AB	1	`79d66fd596c7…`

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ce6fab2-d006-4589-8ba0-02cee499cc60	Product name	2	20260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442	Product name	5	20251106
162160fe-5ea6-4f9d-aa38-c4b780c57046	Product name	1	20250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42	Product name	1	20250312
028fdaca-77da-0dfe-e445-7dfc440fc97e	Product name	4	20250224
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	7	20241218
6a098371-84f5-7ced-0ac5-ed90d535b476	Product name	6	20220927
de702a02-e9c0-4daf-9101-e44f2c0d4e66	Product name	1	20220609
681917df-580c-4199-896d-b739fbb25ed3	Product name	1	20190412
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	4	20171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41	Product name	1	20150313
88839c8d-b65b-4a50-997b-4c74539855ff	Product name	1	20150313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52427-809	STALEVO (CARBIDOPA, LEVODOPA, AND ENTACAPONE) TABLET, FILM COATED [ALMATICA PHARMA LLC]	5	Legacy NDC	20241011_53c488d8-4146-7563-8021-d90c931d1a95.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa, Levodopa, and Entacapone	CARBIDOPA, LEVODOPA, AND ENTACAPONE	Sandoz Inc	9c16c0e0-3b97-486b-b7d5-579f5853e2c5	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021485 application number: NDA021485

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MNX7R8C5VO	CARBIDOPA	38821-49-7	CARBIDOPA
4975G9NM6T	ENTACAPONE	130929-57-6	ENTACAPONE
46627O600J	LEVODOPA	59-92-7	LEVODOPA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52427-809-01	52427080901	1 BOTTLE in 1 CARTON (52427-809-01) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-10-05	0000-00-00	No	No	Current