CARBIDOPA AND LEVODOPA

Product NDC: 62756-519
Requested package NDC: 62756-519-83
11-digit product format: 627560519
Labeler code: 62756
Product ID: 62756-519_d77ed25a-588d-4d22-855f-f93ba5b4003c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBIDOPA AND LEVODOPA
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA078536
Marketing category: ANDA
Marketing start: 2008-10-28
Marketing end: 2023-06-30
Substance: CARBIDOPA; LEVODOPA
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62756-519	62756-519-83	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078536-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28
A078536-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28
A078536-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078536-001	AB
A078536-002	AB
A078536-003	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 4 · 129 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	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2008-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2008-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078536-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2008-10-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A078536-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078536-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078536-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078536-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078536-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078536-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078536-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078536-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078536-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078536-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078536-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078536-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078536-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078536-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078536-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078536-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078536-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078536-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078536-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

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
62756-519-08	CARBIDOPA AND LEVODOPA	100 in 1 BOTTLE	TABLET	100	17
62756-519-13	CARBIDOPA AND LEVODOPA	500 in 1 BOTTLE	TABLET	500	17
62756-519-18	CARBIDOPA AND LEVODOPA	1000 in 1 BOTTLE	TABLET	1000	17
62756-519-83	CARBIDOPA AND LEVODOPA	30 in 1 BOTTLE	TABLET	30	17
62756-519-88	CARBIDOPA AND LEVODOPA	100 in 1 BOTTLE	TABLET	100	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-519-13	EA - Each	62756-519	8b1777ce-26a9-4e75-b364-9b1521e239ec	1	2012-07-24
62756-519-88	EA - Each	62756-519	4253d315-0a07-4273-ae3d-6a1a50458fd0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-519	CARBIDOPA AND LEVODOPA TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	17	Legacy NDC, 5 package rows	20210814_829c35f9-ace0-11dd-8800-f3e252b43544.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	NuCare Pharmaceuticals,Inc.	ad2ab0c4-188b-f025-e053-2a95a90a2816	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078536 application number: ANDA078536
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	db4198da-7ccc-4283-95ad-74bc98435cac	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078536 application number: ANDA078536
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	829c35f9-ace0-11dd-8800-f3e252b43544	2021-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078536 application number: ANDA078536 ndc (package): 62756-519-83 ndc (product): 62756-519 ndc11 (package): 62756051983

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	829c35f9-ace0-11dd-8800-f3e252b43544	17
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	PSN	829c35f9-ace0-11dd-8800-f3e252b43544	17
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	PSN	829c35f9-ace0-11dd-8800-f3e252b43544	17
197443	carbidopa 10 MG / levodopa 100 MG Oral Tablet	SCD	829c35f9-ace0-11dd-8800-f3e252b43544	17
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	SCD	829c35f9-ace0-11dd-8800-f3e252b43544	17
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	SCD	829c35f9-ace0-11dd-8800-f3e252b43544	17
197443	carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral Tablet	SY	829c35f9-ace0-11dd-8800-f3e252b43544	17
197444	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet	SY	829c35f9-ace0-11dd-8800-f3e252b43544	17
197445	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral Tablet	SY	829c35f9-ace0-11dd-8800-f3e252b43544	17
197443	Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet	SY	829c35f9-ace0-11dd-8800-f3e252b43544	17
197444	Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet	SY	829c35f9-ace0-11dd-8800-f3e252b43544	17
197445	Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet	SY	829c35f9-ace0-11dd-8800-f3e252b43544	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-519-83	62756051983	30 TABLET in 1 BOTTLE (62756-519-83)	30 tablet	2008-10-28	2023-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Tablets, USP	Bryant Ranch Prepack	2022-04-20	HUMAN PRESCRIPTION DRUG LABEL	102
Carbidopa and Levodopa Tablets, USP	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2021-08-13	Human Prescription Drug Label	17