Home NDC 52427-809-01 Stalevo
Product NDC 52427-809
Requested package NDC 52427-809-01
11-digit product format 524270809
Labeler code 52427
Product ID 52427-809_e400f8d7-39a0-1b94-222b-73dc9403ba4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbidopa, levodopa, and entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Almatica Pharma LLC
Application NDA021485
Marketing category NDA
Marketing start 2020-10-05
Marketing end 0000-00-00
Substance CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength 19 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 2023-12-31
Current FDA listing Historical FDA.report record 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.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52427-809 STALEVO (CARBIDOPA, LEVODOPA, AND ENTACAPONE) TABLET, FILM COATED [ALMATICA PHARMA LLC] 5 Legacy NDC 20241011_53c488d8-4146-7563-8021-d90c931d1a95.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52427-809-01 52427080901 1 BOTTLE in 1 CARTON (52427-809-01) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-10-05 0000-00-00 No No Current