Home NDC 63629-9154 CARBIDOPA AND LEVODOPA
Product NDC 63629-9154
11-digit product format 636299154
Labeler code 63629
Product ID 63629-9154_e0924b5a-26ad-49ca-98e6-46f6451b1901
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBIDOPA AND LEVODOPA
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078536
Marketing category ANDA
Marketing start 2021-08-12
Substance CARBIDOPA; LEVODOPA
Active strength 25; 250 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 RLD / RS 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.
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 RLD / RS 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.
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBIDOPA 25 mg/1 LEVODOPA 250 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 197445 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-9154-1 CARBIDOPA AND LEVODOPA 100 in 1 BOTTLE TABLET 100 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9154 CARBIDOPA AND LEVODOPA TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240113_db4198da-7ccc-4283-95ad-74bc98435cac.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-9154-1 63629915401 100 TABLET in 1 BOTTLE (63629-9154-1) 100 tablet 2022-01-27 0000-00-00 No No Current