Home NDC 64679-782 CARBIDOPA, LEVODOPA AND ENTACAPONE
Product NDC 64679-782
11-digit product format 646790782
Labeler code 64679
Product ID 64679-782_337712b0-f220-4f72-ba81-7ffdcb9643b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbidopa, levodopa and entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt USA LLC.
Application NDA021485
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-02-29
Marketing end 0000-00-00
Substance LEVODOPA; ENTACAPONE; CARBIDOPA
Active strength 50 mg/1; mg/1; mg/1
Pharmacologic classes Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-782-04 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64679-782-04 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64679-782-04 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64679-782-04 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64679-782-04 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64679-782-04 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64679-782-04 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64679-782-04 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64679-782-04 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64679-782-04 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64679-782-04 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 252 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 2026-08-18 06:07:40 2026-07 N021485-001 STALEVO 50 12.5MG;200MG;50MG TABLET / ORAL AB RLD, RS 2003-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021485-002 STALEVO 100 25MG;200MG;100MG TABLET / ORAL AB RLD 2003-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021485-003 STALEVO 150 37.5MG;200MG;150MG TABLET / ORAL AB RLD 2003-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021485-004 STALEVO 200 50MG;200MG;200MG TABLET / ORAL AB RLD, RS 2007-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021485-005 STALEVO 75 18.75MG;200MG;75MG TABLET / ORAL AB RLD 2008-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021485-006 STALEVO 125 31.25MG;200MG;125MG TABLET / ORAL AB RLD 2008-08-29 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 220 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 64679-782-04 2020-02-21 C162847 48780-1 9d75b9d0-bc89-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use carbidopa, levodopa and entacapone tablets safely and effectively. See full prescribing information for carbidopa, levodopa and entacapone tablets. Carbidopa, Levodopa and Entacapone tablets, for oral use Initial U.S. Approval:2003 64679-782-04 2020-01-31 C162847 48780-1 9d75b9d0-bc89-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use carbidopa, levodopa and entacapone tablets safely and effectively. See full prescribing information for carbidopa, levodopa and entacapone tablets. Carbidopa, Levodopa and Entacapone tablets, for oral use Initial U.S. Approval:2003
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 [WOCKHARDT USA LLC.] 4 ENTACAPONE ACTIVE INGREDIENT 4975G9NM6T CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 LEVODOPA ACTIVE INGREDIENT 46627O600J CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 CARBIDOPA ANHYDROUS ACTIVE MOIETY KR87B45RGH CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 ENTACAPONE ACTIVE MOIETY 4975G9NM6T CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 LEVODOPA ACTIVE MOIETY 46627O600J CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 4
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64679-782-04 64679078204 100 TABLET, FILM COATED in 1 BOTTLE (64679-782-04) 2014-04-08 0000-00-00 No No Current