Stalevo

Product NDC
52427-816
11-digit product format
524270816
Labeler code
52427
Product ID
52427-816_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
25 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52427-816DDiscontinued by firm2026-08-17
excluded packagepackage52427-81652427-816-01DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021485-001STALEVO 50CARBIDOPA; ENTACAPONE; LEVODOPA12.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-11
N021485-002STALEVO 100CARBIDOPA; ENTACAPONE; LEVODOPA25MG;200MG;100MGTABLET / ORALABRLD2003-06-11
N021485-003STALEVO 150CARBIDOPA; ENTACAPONE; LEVODOPA37.5MG;200MG;150MGTABLET / ORALABRLD2003-06-11
N021485-004STALEVO 200CARBIDOPA; ENTACAPONE; LEVODOPA50MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-02
N021485-005STALEVO 75CARBIDOPA; ENTACAPONE; LEVODOPA18.75MG;200MG;75MGTABLET / ORALABRLD2008-08-29
N021485-006STALEVO 125CARBIDOPA; ENTACAPONE; LEVODOPA31.25MG;200MG;125MGTABLET / ORALABRLD2008-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N021485-001AB
N021485-002AB
N021485-003AB
N021485-004AB
N021485-005AB
N021485-006AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021485-001STALEVO 5012.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-002STALEVO 10025MG;200MG;100MGTABLET / ORALABRLD2003-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-003STALEVO 15037.5MG;200MG;150MGTABLET / ORALABRLD2003-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-004STALEVO 20050MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-02caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-005STALEVO 7518.75MG;200MG;75MGTABLET / ORALABRLD2008-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-006STALEVO 12531.25MG;200MG;125MGTABLET / ORALABRLD2008-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021485-001STALEVO 5012.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-002STALEVO 10025MG;200MG;100MGTABLET / ORALABRLD2003-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-003STALEVO 15037.5MG;200MG;150MGTABLET / ORALABRLD2003-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-004STALEVO 20050MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-005STALEVO 7518.75MG;200MG;75MGTABLET / ORALABRLD2008-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-006STALEVO 12531.25MG;200MG;125MGTABLET / ORALABRLD2008-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-001STALEVO 5012.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-002STALEVO 10025MG;200MG;100MGTABLET / ORALABRLD2003-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-003STALEVO 15037.5MG;200MG;150MGTABLET / ORALABRLD2003-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-004STALEVO 20050MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-005STALEVO 7518.75MG;200MG;75MGTABLET / ORALABRLD2008-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-006STALEVO 12531.25MG;200MG;125MGTABLET / ORALABRLD2008-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021485-001STALEVO 5012.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-002STALEVO 10025MG;200MG;100MGTABLET / ORALABRLD2003-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-003STALEVO 15037.5MG;200MG;150MGTABLET / ORALABRLD2003-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-004STALEVO 20050MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-005STALEVO 7518.75MG;200MG;75MGTABLET / ORALABRLD2008-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-006STALEVO 12531.25MG;200MG;125MGTABLET / ORALABRLD2008-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-001STALEVO 5012.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-002STALEVO 10025MG;200MG;100MGTABLET / ORALABRLD2003-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-003STALEVO 15037.5MG;200MG;150MGTABLET / ORALABRLD2003-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-004STALEVO 20050MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-005STALEVO 7518.75MG;200MG;75MGTABLET / ORALABRLD2008-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-006STALEVO 12531.25MG;200MG;125MGTABLET / ORALABRLD2008-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-001STALEVO 5012.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-002STALEVO 10025MG;200MG;100MGTABLET / ORALABRLD2003-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-003STALEVO 15037.5MG;200MG;150MGTABLET / ORALABRLD2003-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-004STALEVO 20050MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-005STALEVO 7518.75MG;200MG;75MGTABLET / ORALABRLD2008-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-006STALEVO 12531.25MG;200MG;125MGTABLET / ORALABRLD2008-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-001STALEVO 5012.5MG;200MG;50MGTABLET / ORALABRLD, RS2003-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-002STALEVO 10025MG;200MG;100MGTABLET / ORALABRLD2003-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-003STALEVO 15037.5MG;200MG;150MGTABLET / ORALABRLD2003-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-004STALEVO 20050MG;200MG;200MGTABLET / ORALABRLD, RS2007-08-0203ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021485-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021485-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021485-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021485-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021485-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021485-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021485-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021485-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021485-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021485-004AB103ed91905a0d…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021485-00165008672020-06-29U-219Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00167977322020-06-29Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00265008672020-06-29U-219Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00267977322020-06-29Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00365008672020-06-29U-219Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00367977322020-06-29Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00465008672020-06-29U-219Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00467977322020-06-29Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00565008672020-06-29U-219Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00567977322020-06-29Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00665008672020-06-29U-219Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021485-00667977322020-06-29Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021485-00165008672020-06-29U-219Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00167977322020-06-29Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00265008672020-06-29U-219Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00267977322020-06-29Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00365008672020-06-29U-219Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00367977322020-06-29Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00465008672020-06-29U-219Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00467977322020-06-29Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00565008672020-06-29U-219Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00567977322020-06-29Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00665008672020-06-29U-219Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021485-00667977322020-06-29Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021485-00165008672020-06-29U-219Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00167977322020-06-29Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00265008672020-06-29U-219Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00267977322020-06-29Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00365008672020-06-29U-219Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00367977322020-06-29Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00465008672020-06-29U-219Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00467977322020-06-29Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00565008672020-06-29U-219Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00567977322020-06-29Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00665008672020-06-29U-219Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021485-00667977322020-06-29Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021485-00165008672020-06-29U-219Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021485-00167977322020-06-29Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021485-00265008672020-06-29U-219Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021485-00267977322020-06-29Drug product3f01610625f2…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
6a098371-84f5-7ced-0ac5-ed90d535b476Product name620220927
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-816STALEVO (CARBIDOPA, LEVODOPA, AND ENTACAPONE) TABLET, FILM COATED [ALMATICA PHARMA LLC]5Legacy NDC20241011_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa, Levodopa, and EntacaponeCARBIDOPA, LEVODOPA, AND ENTACAPONESandoz Inc9c16c0e0-3b97-486b-b7d5-579f5853e2c52026-03-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021485
application number: NDA021485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52427-816-01524270816011 BOTTLE in 1 CARTON (52427-816-01) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-050000-00-00NoNoCurrent