Dhivy

Product NDC: 75854-701
11-digit product format: 758540701
Labeler code: 75854
Product ID: 75854-701_229fe84b-2986-42f6-877c-17d9da08b12c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: Avion Pharmaceuticals, LLC
Application: NDA214869
Marketing category: NDA
Marketing start: 2022-07-13
Substance: CARBIDOPA HYDRATE; 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214869-001	DHIVY	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL		RLD, RS	2021-11-12

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22
N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22
N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22
N214869-001	11439613	2039-03-28	U-3557		2023-04-18
N214869-001	11819485	2039-03-28	U-3557		2023-12-07

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214869-001	DHIVY	25MG;100MG	TABLET / ORAL	RLD, RS	2021-11-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 137 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11033521	2039-03-28	U-219	Drug product	2022-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11033521	2039-03-28	U-3304	Drug product	2022-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11033521	2039-03-28	U-3305	Drug product	2022-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11439613	2039-03-28	U-3557		2023-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214869-001	11819485	2039-03-28	U-3557		2023-12-07	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dhivy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBIDOPA HYDRATE	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
197444	Internal RxNorm lookup
2586032	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
39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	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
75854-701-01	Dhivy	100 in 1 BOTTLE	TABLET	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75854-701-01	EA - Each	75854-701	a04e2fbf-7a05-4235-80e2-c2a60c5df453	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75854-701	DHIVY (CARBIDOPA LEVODOPA) TABLET [AVION PHARMACEUTICALS, LLC]	11	Current NDC, Legacy NDC, 1 package rows	20240202_39d79ade-8ee0-40ba-9fdd-13045b8ddbdf.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dhivy	CARBIDOPA LEVODOPA	Avion Pharmaceuticals, LLC	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214869 application number: NDA214869 ndc (product): 75854-701

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
46627O600J	LEVODOPA	59-92-7	LEVODOPA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	PSN	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13
2586032	Dhivy 25 MG / 100 MG Oral Tablet	PSN	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13
2586032	carbidopa 25 MG / levodopa 100 MG Oral Tablet [Dhivy]	SBD	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	SCD	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13
197444	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet	SY	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13
197444	Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet	SY	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13
2586032	carbidopa 25 MG / L-DOPA 100 MG Oral Tablet [Dhivy]	SY	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13
2586032	Dhivy (carbidopa 25 MG / levodopa 100 MG) Oral Tablet	SY	39d79ade-8ee0-40ba-9fdd-13045b8ddbdf	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75854-701-01	75854070101	100 TABLET in 1 BOTTLE (75854-701-01)	100 tablet	2022-07-13	0000-00-00	No	No	Current