RYTARY

Product NDC: 64896-663
11-digit product format: 648960663
Labeler code: 64896
Product ID: 64896-663_ef3fe5ab-c753-409b-a5f3-b55e3eefd070
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: NDA203312
Marketing category: NDA
Marketing start: 2015-01-12
Substance: CARBIDOPA HYDRATE; LEVODOPA
Active strength: 48.75; 195 mg/1; mg/1
Pharmacologic classes: Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N203312-001	RYTARY	CARBIDOPA; LEVODOPA	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07
N203312-002	RYTARY	CARBIDOPA; LEVODOPA	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07
N203312-003	RYTARY	CARBIDOPA; LEVODOPA	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07
N203312-004	RYTARY	CARBIDOPA; LEVODOPA	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07

Orange Book patents#

Current patent rows page 1 of 1 · 60 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203312-001	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-001	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-001	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-001	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-001	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-001	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-001	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-001	9089608	2028-12-26		Drug product	2015-08-10
N203312-001	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-001	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-001	9901640	2028-12-26	U-219	Drug product	2018-02-28
N203312-002	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-002	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-002	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-002	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-002	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-002	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-002	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-002	9089608	2028-12-26		Drug product	2015-08-10
N203312-002	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-002	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-002	9901640	2028-12-26	U-219	Drug product	2018-02-28
N203312-003	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-003	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-003	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-003	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-003	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-003	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-003	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-003	9089608	2028-12-26		Drug product	2015-08-10
N203312-003	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-003	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-003	9901640	2028-12-26	U-219	Drug product	2018-02-28
N203312-004	8377474	2028-12-26	U-1645	Drug product	2015-01-27
N203312-004	8377474	2028-12-26	U-219	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1645	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1646	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1647	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-1649	Drug product	2015-01-27
N203312-004	8454998	2028-12-26	U-219	Drug product	2015-01-27
N203312-004	8557283	2028-12-26	U-1645	Drug product	2015-01-27
N203312-004	8557283	2028-12-26	U-219	Drug product	2015-01-27
N203312-004	9089607	2028-12-26	U-1645	Drug product	2015-08-10
N203312-004	9089607	2028-12-26	U-1720	Drug product	2015-08-10
N203312-004	9089608	2028-12-26		Drug product	2015-08-10
N203312-004	9463246	2028-12-26	U-219	Drug product	2016-10-12
N203312-004	9533046	2028-12-26	U-219	Drug product	2017-01-11
N203312-004	9901640	2028-12-26	U-219	Drug product	2018-02-28

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203312-001	RYTARY	23.75MG;95MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203312-002	RYTARY	36.25MG;145MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203312-003	RYTARY	48.75MG;195MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2015-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203312-004	RYTARY	61.25MG;245MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2015-01-07	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 64 · 2,532 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203312-001	8377474	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8377474	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1649	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1646	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-1647	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8454998	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8557283	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	8557283	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9089607	2028-12-26	U-1645	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9089607	2028-12-26	U-1720	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9089608	2028-12-26		Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9463246	2028-12-26	U-219	Drug product	2016-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9533046	2028-12-26	U-219	Drug product	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-001	9901640	2028-12-26	U-219	Drug product	2018-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8377474	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8377474	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1649	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1647	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8454998	2028-12-26	U-1646	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8557283	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	8557283	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9089607	2028-12-26	U-1645	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9089607	2028-12-26	U-1720	Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9089608	2028-12-26		Drug product	2015-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9463246	2028-12-26	U-219	Drug product	2016-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9533046	2028-12-26	U-219	Drug product	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-002	9901640	2028-12-26	U-219	Drug product	2018-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8377474	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8377474	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1647	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1649	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8454998	2028-12-26	U-1646	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8557283	2028-12-26	U-1645	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	8557283	2028-12-26	U-219	Drug product	2015-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203312-003	9089607	2028-12-26	U-1645	Drug product	2015-08-10	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: RYTARY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVODOPA	48.75 mg/1
CARBIDOPA HYDRATE	195 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
46627O600J	Internal UNII lookup
MNX7R8C5VO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1600773	Internal RxNorm lookup
1600774	Internal RxNorm lookup
1600775	Internal RxNorm lookup
1600776	Internal RxNorm lookup
1600914	Internal RxNorm lookup
1600915	Internal RxNorm lookup
1600916	Internal RxNorm lookup
1600917	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	Available on FDA.report

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
de702a02-e9c0-4daf-9101-e44f2c0d4e66	Product name	1	20220609
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64896-663-01	RYTARY	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	26
64896-663-09	RYTARY	25 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	25	26
64896-663-43	RYTARY	240 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	240	26
64896-663-99	RYTARY	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64896-663-01	EA - Each	64896-663	232522ba-49dc-4354-aa9f-6448558e2aba	1	2015-02-02
64896-663-09	EA - Each	64896-663	0c124482-a02c-44ef-abbb-fa2be9477228	1	2019-03-12
64896-663-43	EA - Each	64896-663	355d7bcf-b504-4e2e-9398-a09d2592443e	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Carbidopa	ACTIVE INGREDIENT	MNX7R8C5VO	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Levodopa	ACTIVE INGREDIENT	46627O600J	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Carbidopa Anhydrous	ACTIVE MOIETY	KR87B45RGH	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Levodopa	ACTIVE MOIETY	46627O600J	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Hypromellose 2910 (6 Mpa.S)	INACTIVE INGREDIENT	0WZ8WG20P6	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)	INACTIVE INGREDIENT	74G4R6TH13	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)	INACTIVE INGREDIENT	5KY68S2577	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Povidones	INACTIVE INGREDIENT	FZ989GH94E	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Tartaric Acid	INACTIVE INGREDIENT	W4888I119H	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2
Triethyl Citrate	INACTIVE INGREDIENT	8Z96QXD6UM	RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64896-663	RYTARY (CARBIDOPA AND LEVODOPA) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	22	Current NDC, Legacy NDC, 4 package rows	20241025_6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	4ce99f65-5857-448c-b22a-9b3b64de69e2	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	b29e58f0-67b1-4036-a4a8-4915a8c13cdf	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	beedd327-bbc5-4f17-838a-4e72bf0867f0	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	9ac804f1-7e15-48bc-8ae9-25181a629dd4	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312
RYTARY	CARBIDOPA AND LEVODOPA	Amneal Pharmaceuticals LLC	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312 ndc (product): 64896-663
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Zydus Pharmaceuticals USA Inc.	74e7f96b-de31-4e3c-b32d-11421b291d4e	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203312 application number: NDA203312

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
46627O600J	LEVODOPA	59-92-7	LEVODOPA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1600773	carbidopa 23.75 MG / levodopa 95 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600775	carbidopa 36.25 MG / levodopa 145 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600914	carbidopa 48.75 MG / levodopa 195 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600916	carbidopa 61.25 MG / levodopa 245 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600774	RYTARY 23.75 MG / 95 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600776	RYTARY 36.25 MG /145 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600915	RYTARY 48.75 MG / 195 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600917	RYTARY 61.25 MG / 245 MG 8HR Extended Release Oral Capsule	PSN	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600774	8 HR carbidopa 23.75 MG / levodopa 95 MG Extended Release Oral Capsule [Rytary]	SBD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600776	8 HR carbidopa 36.25 MG / levodopa 145 MG Extended Release Oral Capsule [Rytary]	SBD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600915	8 HR carbidopa 48.75 MG / levodopa 195 MG Extended Release Oral Capsule [Rytary]	SBD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600917	8 HR carbidopa 61.25 MG / levodopa 245 MG Extended Release Oral Capsule [Rytary]	SBD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600773	8 HR carbidopa 23.75 MG / levodopa 95 MG Extended Release Oral Capsule	SCD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600775	8 HR carbidopa 36.25 MG / levodopa 145 MG Extended Release Oral Capsule	SCD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600914	8 HR carbidopa 48.75 MG / levodopa 195 MG Extended Release Oral Capsule	SCD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600916	8 HR carbidopa 61.25 MG / levodopa 245 MG Extended Release Oral Capsule	SCD	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600773	8 HR Carbidopa 23.75 MG / L-DOPA 95 MG Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600774	8 HR Carbidopa 23.75 MG / L-DOPA 95 MG Extended Release Oral Capsule [Rytary]	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600775	8 HR Carbidopa 36.25 MG / L-DOPA 145 MG Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600776	8 HR Carbidopa 36.25 MG / L-DOPA 145 MG Extended Release Oral Capsule [Rytary]	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600914	8 HR Carbidopa 48.75 MG / L-DOPA 195 MG Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600915	8 HR Carbidopa 48.75 MG / L-DOPA 195 MG Extended Release Oral Capsule [Rytary]	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600916	8 HR Carbidopa 61.25 MG / L-DOPA 245 MG Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600917	8 HR Carbidopa 61.25 MG / L-DOPA 245 MG Extended Release Oral Capsule [Rytary]	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600773	carbidopa 23.75 MG / levodopa 95 MG 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600775	carbidopa 36.25 MG / levodopa 145 MG 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600914	carbidopa 48.75 MG / levodopa 195 MG 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600916	carbidopa 61.25 MG / levodopa 245 MG 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600774	Rytary (carbidopa 23.75 MG / levodopa 95 MG) 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600776	Rytary (carbidopa 36.25 MG / levodopa 145 MG) 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600915	Rytary (carbidopa 48.75 MG / levodopa 195 MG) 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26
1600917	Rytary (carbidopa 61.25 MG / levodopa 245 MG) 8 HR Extended Release Oral Capsule	SY	6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64896-663-01	64896066301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-01)	2015-01-12	0000-00-00	No	No	Current
64896-663-09	64896066309	25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-09)	2015-01-12	0000-00-00	No	No	Current
64896-663-43	64896066343	240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-43)	2015-01-12	0000-00-00	No	No	Current
64896-663-99	64896066399	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-663-99)	2015-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RYTARY	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited \| BORA PHARMACEUTICAL LABORATORIES INC. \| Reed-Lane, Inc.	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL	26