Carbidopa-levodopa

Product NDC: 68002-100
11-digit product format: 680020100
Labeler code: 68002
Product ID: 68002-100_3a9d54e8-0ed9-4e71-e063-6394a90ac4ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa and levodopa
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA216505
Marketing category: ANDA
Marketing start: 2025-07-28
Substance: CARBIDOPA; LEVODOPA
Active strength: 10; 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 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
A216505-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21
A216505-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21
A216505-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216505-001	AB
A216505-002	AB
A216505-003	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.

Product history page 1 of 3 · 84 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
2026-09-14 22:38:34	2026-08	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216505-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216505-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216505-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-09-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216505-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216505-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216505-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216505-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216505-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216505-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216505-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216505-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216505-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216505-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216505-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216505-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216505-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216505-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216505-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216505-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216505-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216505-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216505-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216505-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216505-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216505-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216505-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216505-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216505-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216505-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216505-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216505-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216505-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216505-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216505-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216505-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216505-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216505-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216505-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216505-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216505-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216505-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216505-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216505-001	AB	1	`301d65b070ca…`

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-levodopa
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBIDOPA	10 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
197443	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
dd2215a9-ee0f-443a-a2e3-3d0578c8cd8f	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
68002-100-02	Carbidopa-levodopa	1 in 1 BLISTER PACK	TABLET	1		1
68002-100-04	Carbidopa-levodopa	30 in 1 CARTON	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68002-100-02	EA - Each	68002-100	b4889ac5-4266-4466-9b2f-8ad97005ac2e	1	2025-08-11
68002-100-04	EA - Each	68002-100	6673a4f8-a874-48dd-b763-5db08eafe0c2	1	2025-08-11

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-levodopa	CARBIDOPA AND LEVODOPA	Advagen Pharma Ltd.,	9e3c796b-2e68-4bcc-b927-18a58bea4703	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216505 application number: ANDA216505
Carbidopa-levodopa	CARBIDOPA AND LEVODOPA	American Health Packaging	dd2215a9-ee0f-443a-a2e3-3d0578c8cd8f	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216505 application number: ANDA216505 ndc (product): 68002-100
Carbidopa-levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	c3f17bad-f486-4529-90df-5fdab3cb1d0b	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216505 application number: ANDA216505
Carbidopa-levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	2cdca970-f077-3a80-e063-6294a90ab335	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216505 application number: ANDA216505
Carbidopa-levodopa	CARBIDOPA AND LEVODOPA	TruPharma, LLC	d1bb319b-82a3-4b66-9cdc-f77fdb8383ce	2023-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216505 application number: ANDA216505

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
197443	carbidopa 10 MG / levodopa 100 MG Oral Tablet	PSN	dd2215a9-ee0f-443a-a2e3-3d0578c8cd8f	1
197443	carbidopa 10 MG / levodopa 100 MG Oral Tablet	SCD	dd2215a9-ee0f-443a-a2e3-3d0578c8cd8f	1
197443	carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral Tablet	SY	dd2215a9-ee0f-443a-a2e3-3d0578c8cd8f	1
197443	Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet	SY	dd2215a9-ee0f-443a-a2e3-3d0578c8cd8f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68002-100-02	68002010002	1 in 1 BLISTER PACK					Historical
68002-100-04	68002010004	30 BLISTER PACK in 1 CARTON (68002-100-04) / 1 TABLET in 1 BLISTER PACK (68002-100-02)	30 blister pack	2025-07-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Tablets USP 8610004/0425 Rx only	American Health Packaging	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	1