Carbidopa and Levodopa

Product NDC: 46708-332
11-digit product format: 467080332
Labeler code: 46708
Product ID: 46708-332_a85a56c5-44dd-41d4-ac1c-bdc4758406a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA210341
Marketing category: ANDA
Marketing start: 2019-06-06
Substance: CARBIDOPA; LEVODOPA
Active strength: 25; 100 mg/1; mg/1
Pharmacologic classes: Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210341-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-06-05
A210341-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210341-001	AB
A210341-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210341-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210341-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210341-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210341-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210341-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210341-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210341-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210341-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210341-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210341-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210341-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210341-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210341-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210341-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210341-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210341-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210341-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210341-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210341-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210341-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210341-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210341-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210341-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210341-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210341-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210341-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210341-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210341-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210341-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210341-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210341-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210341-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210341-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210341-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210341-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210341-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210341-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210341-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210341-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210341-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210341-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210341-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carbidopa and Levodopa
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBIDOPA	25 mg/1
LEVODOPA	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308988	Internal RxNorm lookup
308989	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
a85a56c5-44dd-41d4-ac1c-bdc4758406a4	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
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
46708-332-30	Carbidopa and Levodopa	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1
46708-332-31	Carbidopa and Levodopa	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	1
46708-332-91	Carbidopa and Levodopa	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-332	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, Legacy NDC, 3 package rows	20190611_a85a56c5-44dd-41d4-ac1c-bdc4758406a4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Alembic Pharmaceuticals Inc.	ac18e5fa-e2ee-4aa5-8d0f-94b63a076e66	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210341 application number: ANDA210341
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Alembic Pharmaceuticals Limited	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	2019-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210341 application number: ANDA210341 ndc (product): 46708-332

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	PSN	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	PSN	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	SCD	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	SCD	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1
308988	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral Tablet	SY	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1
308989	carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral Tablet	SY	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1
308988	Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral Tablet	SY	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1
308989	Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral Tablet	SY	a85a56c5-44dd-41d4-ac1c-bdc4758406a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-332-30	46708033230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-30)	2019-06-06	0000-00-00	No	No	Current
46708-332-31	46708033231	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-31)	2019-06-06	0000-00-00	No	No	Current
46708-332-91	46708033291	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-91)	2019-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Extended-Release Tablets, USP Rx Only	Alembic Pharmaceuticals Limited	2019-06-06	Human Prescription Drug Label	1