CARBIDOPA AND LEVODOPA

Product NDC: 53401-020
11-digit product format: 534010020
Labeler code: 53401
Product ID: 53401-020_5644f547-ed81-4b19-e063-6394a90a014b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA218939
Marketing category: ANDA
Marketing start: 2026-01-19
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218939-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14
A218939-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14
A218939-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A218939-001	AB
A218939-002	AB
A218939-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218939-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2025-01-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218939-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2025-01-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218939-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2025-01-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218939-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218939-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218939-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218939-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218939-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218939-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218939-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218939-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218939-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218939-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218939-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218939-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218939-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218939-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218939-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218939-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218939-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218939-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218939-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218939-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218939-003	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218939-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218939-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218939-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

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
197444	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
5644d10f-620e-810e-e063-6294a90af678	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Aphena Pharma Solutions - Tennessee, LLC	5644d10f-620e-810e-e063-6294a90af678	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218939 application number: ANDA218939 ndc (product): 53401-020
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Coupler LLC	500f0cdb-10e1-9545-e063-6394a90a3ad1	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218939 application number: ANDA218939
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	XLCare Pharmaceuticals, Inc.	0c630a24-dc51-4601-a5d6-2f9e397a0449	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218939 application number: ANDA218939
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Camber Pharmaceuticals, Inc.	770ba054-fec4-4833-8096-85c3ce3ae830	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218939 application number: ANDA218939

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	Units	Marketing start	Sample	Exclude flag	Status
53401-020-60	53401002060	90 TABLET in 1 BOTTLE (53401-020-60)	90 tablet	2026-07-09	No	No	Current
53401-020-80	53401002080	180 TABLET in 1 BOTTLE (53401-020-80)	180 tablet	2026-07-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Tablets, USP Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	1