Carbidopa and Levodopa

Product NDC: 72162-2194
11-digit product format: 721622194
Labeler code: 72162
Product ID: 72162-2194_9516718b-f8c3-4cc1-a0eb-3367c8fdcb59
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA214091
Marketing category: ANDA
Marketing start: 2021-10-05
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 42.

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
A214091-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05
A214091-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214091-001	AB
A214091-002	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 2 · 68 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
2026-08-18 06:07:40	2026-07	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2021-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214091-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214091-002	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-10-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214091-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214091-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214091-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214091-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214091-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214091-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214091-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214091-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214091-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214091-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214091-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214091-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214091-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214091-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214091-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214091-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214091-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214091-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214091-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214091-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214091-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214091-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214091-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214091-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214091-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214091-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214091-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214091-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214091-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214091-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214091-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214091-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214091-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214091-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214091-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214091-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214091-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214091-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214091-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214091-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carbidopa and Levodopa
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308988	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
043e58c6-092d-4637-90f1-9d36af143a24	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	Strength	SPL version
72162-2194-1	Carbidopa and Levodopa	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2194-1	EA - Each	72162-2194	d2489d37-8e43-4def-87db-10341bc9cb10	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2194	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	101	Current NDC, 1 package rows	20231219_043e58c6-092d-4637-90f1-9d36af143a24.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	3b06a0e2-bec8-4178-942b-67eb47f2916e	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214091 application number: ANDA214091
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	043e58c6-092d-4637-90f1-9d36af143a24	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214091 application number: ANDA214091 ndc (product): 72162-2194
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Radha Pharmaceuticals Inc	33a22ffe-0d41-162d-e063-6394a90a43d3	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214091 application number: ANDA214091
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	ScieGen Pharmaceuticals Inc	1b17ab1e-f3c1-4343-ba28-e2901cd97d43	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214091 application number: ANDA214091
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	NCS HealthCare of KY, LLC dba Vangard Labs	ef0be743-e6f3-4662-8b0c-53f1eda4638a	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214091 application number: ANDA214091

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	043e58c6-092d-4637-90f1-9d36af143a24	102
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	SCD	043e58c6-092d-4637-90f1-9d36af143a24	102
308988	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral Tablet	SY	043e58c6-092d-4637-90f1-9d36af143a24	102
308988	Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral Tablet	SY	043e58c6-092d-4637-90f1-9d36af143a24	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-2194-1	72162219401	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2194-1)	2023-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Extended-Release Tablets, USP Rx only	Bryant Ranch Prepack	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	103