Home NDC 0378-0085 Carbidopa and Levodopa
Product NDC 0378-0085
11-digit product format 003780085
Labeler code 0378
Product ID 0378-0085_26fe1be4-3d62-438c-a3d3-21999097cbae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbidopa and levodopa
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA090324
Marketing category ANDA
Marketing start 2011-05-16
Marketing end 0000-00-00
Substance CARBIDOPA; LEVODOPA
Active strength 25 mg/1; mg/1
Pharmacologic classes Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A090324-001 CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 10MG;100MG TABLET / ORAL 2009-09-28 A090324-002 CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 A090324-003 CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA 25MG;250MG TABLET / ORAL 2009-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090324-002 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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL 2009-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL 2009-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL 2009-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL 2009-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL 2009-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL 2009-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL 2009-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL 2009-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL 2009-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL 2009-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090324-002 CARBIDOPA AND LEVODOPA 25MG;100MG TABLET / ORAL AB 2009-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090324-003 CARBIDOPA AND LEVODOPA 25MG;250MG TABLET / ORAL AB 2009-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090324-001 CARBIDOPA AND LEVODOPA 10MG;100MG TABLET / ORAL AB 2009-09-28 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0085 CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.] 11 Legacy NDC 20250101_3c768639-8a70-4d12-ad93-827bb42ec6b7.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-0085-01 00378008501 100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01) 100 tablet 2011-05-16 0000-00-00 No No Current