CARBIDOPA AND LEVODOPA

Product NDC: 68001-172
11-digit product format: 680010172
Labeler code: 68001
Product ID: 68001-172_9d0cb864-53d9-4151-b557-dd5114903d6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA202323
Marketing category: ANDA
Marketing start: 2014-01-22
Marketing end: 0000-00-00
Substance: CARBIDOPA; LEVODOPA
Active strength: 50 mg/1; mg/1
Pharmacologic classes: Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	68001-172		D	Discontinued by firm		2026-10-20
excluded package	package	68001-172	68001-172-00	D	Discontinued by firm		2026-10-20

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202323-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2013-02-08
A202323-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2013-02-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202323-001	AB
A202323-002	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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202323-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202323-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-02-08	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202323-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202323-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202323-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202323-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202323-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202323-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202323-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202323-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202323-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202323-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202323-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202323-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202323-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202323-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202323-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202323-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202323-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202323-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202323-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202323-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202323-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202323-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202323-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202323-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202323-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202323-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202323-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202323-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202323-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202323-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202323-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202323-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202323-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202323-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202323-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202323-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202323-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202323-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202323-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202323-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-172-00	EA - Each	68001-172	2bba249d-4ac8-4f1f-8e9b-be2536151b46	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
HYPROMELLOSE 2208 (4000 MPA.S)	INACTIVE INGREDIENT	39J80LT57T	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-172	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7	Legacy NDC	20250322_58a6e76a-f99f-4f0c-9d83-a55a30edda97.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 AND LEVODOPA	CARBIDOPA AND LEVODOPA	Accord Healthcare, Inc.	5217a6ec-cc26-4acc-b2da-17f6545c3b60	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202323 application number: ANDA202323

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MNX7R8C5VO	CARBIDOPA	38821-49-7	CARBIDOPA
46627O600J	LEVODOPA	59-92-7	LEVODOPA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-172-00	68001017200	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-172-00)	2014-01-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Extended-Release Tablets Rx only	BluePoint Laboratories \| Intas Pharmaceuticals Ltd	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	7