Duopa

Product NDC
0074-3012
11-digit product format
000743012
Labeler code
0074
Product ID
0074-3012_3141c7d9-a3c8-4658-8a14-22182f452465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
SUSPENSION
Route
ENTERAL
Labeler
AbbVie Inc.
Application
NDA203952
Marketing category
NDA
Marketing start
2015-01-15
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
4.63; 20 mg/mL; mg/mL
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203952-001DUOPACARBIDOPA; LEVODOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-093f01610625f2…
2019-09-15 20:21 UTC2019-09N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N203952-001DUOPA4.63MG/ML;20MG/MLSUSPENSION / ENTERALRLD, RS2015-01-09cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203952-001ODE-842022-01-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203952-001ODE-842022-01-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203952-001ODE-842022-01-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203952-001ODE-842022-01-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203952-001ODE-842022-01-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203952-001ODE-842022-01-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203952-001ODE-842022-01-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N203952-001ODE-842022-01-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203952-001ODE-842022-01-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203952-001ODE-842022-01-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203952-001ODE-842022-01-093f01610625f2…
2019-09-15 20:21 UTC2019-09N203952-001ODE-842022-01-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N203952-001ODE-842022-01-09ea99ee380514…
2023-01-26 05:58 UTC2023-01N203952-001ODE-842022-01-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203952-001ODE-842022-01-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203952-001ODE-842022-01-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203952-001ODE-842022-01-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N203952-001ODE-842022-01-09cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Duopa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVODOPA4.63 mg/mL
CARBIDOPA HYDRATE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
46627O600JInternal UNII lookup
MNX7R8C5VOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599846Internal RxNorm lookup
1599852Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7066d371-dc6a-0d6f-7bed-e5dd4ee912daAvailable on FDA.report

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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-3012-07Duopa100 mL in 1 CARTRIDGESUSPENSION100171
0074-3012-07Duopa7 in 1 CARTONSUSPENSION7171

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3012-07ML - Milliliter0074-30123c0e9fed-6586-4456-8a49-cc241d8b4f6f12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbidopaACTIVE INGREDIENTMNX7R8C5VODUOPA (CARBIDOPA AND LEVODOPA) SUSPENSION [ABBVIE INC.]119
LevodopaACTIVE INGREDIENT46627O600JDUOPA (CARBIDOPA AND LEVODOPA) SUSPENSION [ABBVIE INC.]119
Carbidopa AnhydrousACTIVE MOIETYKR87B45RGHDUOPA (CARBIDOPA AND LEVODOPA) SUSPENSION [ABBVIE INC.]119
LevodopaACTIVE MOIETY46627O600JDUOPA (CARBIDOPA AND LEVODOPA) SUSPENSION [ABBVIE INC.]119
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311DUOPA (CARBIDOPA AND LEVODOPA) SUSPENSION [ABBVIE INC.]119
WaterINACTIVE INGREDIENT059QF0KO0RDUOPA (CARBIDOPA AND LEVODOPA) SUSPENSION [ABBVIE INC.]119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3012DUOPA (CARBIDOPA AND LEVODOPA) SUSPENSION [ABBVIE INC.]170Current NDC, Legacy NDC, 2 package rows20250523_7066d371-dc6a-0d6f-7bed-e5dd4ee912da.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
DuopaCARBIDOPA AND LEVODOPAAbbVie Inc.7066d371-dc6a-0d6f-7bed-e5dd4ee912da2026-03-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 203952
application number: NDA203952
ndc (product): 0074-3012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599846carbidopa 4.63 MG / levodopa 20 MG in 1 mL Enteral SuspensionPSN7066d371-dc6a-0d6f-7bed-e5dd4ee912da171
1599852Duopa 4.63 MG / 20 MG in 1 mL Enteral SuspensionPSN7066d371-dc6a-0d6f-7bed-e5dd4ee912da171
1599852carbidopa 4.63 MG/ML / levodopa 20 MG/ML Oral Suspension [Duopa]SBD7066d371-dc6a-0d6f-7bed-e5dd4ee912da171
1599846carbidopa 4.63 MG/ML / levodopa 20 MG/ML Oral SuspensionSCD7066d371-dc6a-0d6f-7bed-e5dd4ee912da171
1599846carbidopa 4.63 MG/ML (as carbidopa monohydrate 5 MG/ML) / levodopa 20 MG/ML Oral SuspensionSY7066d371-dc6a-0d6f-7bed-e5dd4ee912da171
1599846carbidopa 4.63 MG/ML / L-DOPA 20 MG/ML Oral SuspensionSY7066d371-dc6a-0d6f-7bed-e5dd4ee912da171
1599852carbidopa 4.63 MG/ML / L-DOPA 20 MG/ML Oral Suspension [Duopa]SY7066d371-dc6a-0d6f-7bed-e5dd4ee912da171
1599852Duopa (carbidopa 4.63 MG/ML (as carbidopa monohydrate 5 MG/ML) / levodopa 20 MG/ML) Enteral SuspensionSY7066d371-dc6a-0d6f-7bed-e5dd4ee912da171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-3012-07000743012077 CARTRIDGE in 1 CARTON (0074-3012-07) / 100 mL in 1 CARTRIDGE7 cartridge2015-01-150000-00-00NoNoCurrent