Carbidopa and Levodopa

Product NDC: 16571-158
11-digit product format: 165710158
Labeler code: 16571
Product ID: 16571-158_bf8b1cec-9b24-4102-b948-08c988bfca91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa and levodopa
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA078893
Marketing category: ANDA
Marketing start: 2025-01-08
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 1.

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
A078893-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18
A078893-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18
A078893-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078893-001	AB
A078893-002	AB
A078893-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078893-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-003	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A078893-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078893-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078893-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078893-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078893-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078893-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078893-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078893-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078893-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078893-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078893-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078893-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078893-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078893-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078893-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078893-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078893-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078893-003	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
476399	Internal RxNorm lookup
476515	Internal RxNorm lookup
483090	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
302bfe03-d222-4a87-80ff-f2dbfb9a07f4	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16571-158-01	Carbidopa and Levodopa	100 in 1 BOTTLE, PLASTIC	TABLET, ORALLY DISINTEGRATING	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-158-01	EA - Each	16571-158	224795f8-19fb-47cc-bc2f-4f77cc2fa90a	1	2025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-158	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 1 package rows	20250413_302bfe03-d222-4a87-80ff-f2dbfb9a07f4.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
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Rising Pharma Holdings, Inc.	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078893 application number: ANDA078893 ndc (product): 16571-158

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
483090	carbidopa 10 MG / levodopa 100 MG Disintegrating Oral Tablet	PSN	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
476399	carbidopa 25 MG / levodopa 100 MG Disintegrating Oral Tablet	PSN	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
476515	carbidopa 25 MG / levodopa 250 MG Disintegrating Oral Tablet	PSN	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
483090	carbidopa 10 MG / levodopa 100 MG Disintegrating Oral Tablet	SCD	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
476399	carbidopa 25 MG / levodopa 100 MG Disintegrating Oral Tablet	SCD	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
476515	carbidopa 25 MG / levodopa 250 MG Disintegrating Oral Tablet	SCD	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
483090	Carbidopa 10 MG / L-DOPA 100 MG Disintegrating Oral Tablet	SY	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
476399	Carbidopa 25 MG / L-DOPA 100 MG Disintegrating Oral Tablet	SY	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4
476515	Carbidopa 25 MG / L-DOPA 250 MG Disintegrating Oral Tablet	SY	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
16571-158-01	16571015801	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-158-01)	2025-01-08	No	No	Current