Home NDC 0781-5654 Carbidopa, Levodopa, and Entacapone
Product NDC 0781-5654
11-digit product format 007815654
Labeler code 0781
Product ID 0781-5654_2176ea25-da6b-47b2-a081-b3da614df0a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbidopa, Levodopa, and Entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application NDA021485
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-06-18
Substance CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength 37.5; 200; 150 mg/1; mg/1; mg/1
Pharmacologic classes Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021485-001 STALEVO 50 CARBIDOPA; ENTACAPONE; LEVODOPA 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 N021485-002 STALEVO 100 CARBIDOPA; ENTACAPONE; LEVODOPA 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 N021485-003 STALEVO 150 CARBIDOPA; ENTACAPONE; LEVODOPA 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 N021485-004 STALEVO 200 CARBIDOPA; ENTACAPONE; LEVODOPA 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 N021485-005 STALEVO 75 CARBIDOPA; ENTACAPONE; LEVODOPA 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 N021485-006 STALEVO 125 CARBIDOPA; ENTACAPONE; LEVODOPA 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 · 246 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 2026-02-19 14:30 UTC 2026-02 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021485-005 STALEVO 75 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021485-006 STALEVO 125 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021485-005 STALEVO 75 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021485-006 STALEVO 125 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021485-005 STALEVO 75 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021485-006 STALEVO 125 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021485-005 STALEVO 75 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021485-006 STALEVO 125 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021485-005 STALEVO 75 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021485-006 STALEVO 125 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021485-005 STALEVO 75 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021485-006 STALEVO 125 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 214 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Carbidopa, Levodopa, and Entacapone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBIDOPA 37.5 mg/1 LEVODOPA 200 mg/1 ENTACAPONE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MNX7R8C5VO Internal UNII lookup 46627O600J Internal UNII lookup 4975G9NM6T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403850 Internal RxNorm lookup 403851 Internal RxNorm lookup 403852 Internal RxNorm lookup 730988 Internal RxNorm lookup 810083 Internal RxNorm lookup 810090 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 0781-5654-01 Carbidopa, Levodopa, and Entacapone 100 in 1 BOTTLE TABLET, FILM COATED 100 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBIDOPA ACTIVE INGREDIENT MNX7R8C5VO CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 ENTACAPONE ACTIVE INGREDIENT 4975G9NM6T CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 LEVODOPA ACTIVE INGREDIENT 46627O600J CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 CARBIDOPA ANHYDROUS ACTIVE MOIETY KR87B45RGH CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 ENTACAPONE ACTIVE MOIETY 4975G9NM6T CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 LEVODOPA ACTIVE MOIETY 46627O600J CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 POVIDONES INACTIVE INGREDIENT FZ989GH94E CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5654 CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 13 Current NDC, Legacy NDC, 1 package rows 20250507_9c16c0e0-3b97-486b-b7d5-579f5853e2c5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-5654-01 00781565401 100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01) 2014-06-18 0000-00-00 No No Current