Inbrija

Product NDC
0259-6142
11-digit product format
002596142
Labeler code
0259
Product ID
0259-6142_d7dccf06-ab71-4821-bda0-da271532a33d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levodopa
Dosage form
CAPSULE
Route
RESPIRATORY (INHALATION)
Labeler
Merz Pharmaceuticals, LLC
Application
NDA209184
Marketing category
NDA
Marketing start
2018-12-22
Substance
LEVODOPA
Active strength
42 mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N209184-001INBRIJALEVODOPA42MGPOWDER / INHALATIONRLD, RS2018-12-21

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209184-001RE437112029-02-03U-24842019-01-18
N209184-00185458782032-11-16Drug product2019-01-18
N209184-00186854422032-11-16Drug product2019-01-18
N209184-00189456122032-11-16Drug product2019-01-18
N209184-00193932102032-11-16Drug product2019-01-18
N209184-001124586152033-10-21U-24842025-11-26

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 10 · 395 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209184-001RE437112029-02-03U-24842019-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209184-00185458782032-11-16Drug product2019-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209184-00186854422032-11-16Drug product2019-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209184-00189456122032-11-16Drug product2019-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209184-00193932102032-11-16Drug product2019-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209184-001124586152033-10-21U-24842025-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209184-001RE437112029-02-03U-24842019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209184-00185458782032-11-16Drug product2019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209184-00186854422032-11-16Drug product2019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209184-00189456122032-11-16Drug product2019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209184-00193932102032-11-16Drug product2019-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209184-001124586152033-10-21U-24842025-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209184-001RE437112029-02-03U-24842019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209184-00185458782032-11-16Drug product2019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209184-00186854422032-11-16Drug product2019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209184-00189456122032-11-16Drug product2019-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209184-00193932102032-11-16Drug product2019-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209184-001RE437112029-02-03U-24842019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209184-00185458782032-11-16Drug product2019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209184-00186854422032-11-16Drug product2019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209184-00189456122032-11-16Drug product2019-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209184-00193932102032-11-16Drug product2019-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209184-001RE437112029-02-03U-24842019-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209184-00185458782032-11-16Drug product2019-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209184-00186854422032-11-16Drug product2019-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209184-00189456122032-11-16Drug product2019-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209184-00193932102032-11-16Drug product2019-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209184-001RE437112029-02-03U-24842019-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209184-00185458782032-11-16Drug product2019-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209184-00186854422032-11-16Drug product2019-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209184-00189456122032-11-16Drug product2019-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209184-00193932102032-11-16Drug product2019-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209184-00171829612024-02-22Drug product2019-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209184-001RE437112029-02-03U-24842019-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209184-00185458782032-11-16Drug product2019-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209184-00186854422032-11-16Drug product2019-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209184-00189456122032-11-16Drug product2019-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209184-00193932102032-11-16Drug product2019-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209184-00171829612024-02-22Drug product2019-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209184-001RE437112029-02-03U-24842019-01-182680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N209184-001NP2021-12-2174a2ff9319b5…
2021-12-28 21:50 UTC2021-12N209184-001NP2021-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209184-001NP2021-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N209184-001NP2021-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209184-001NP2021-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209184-001NP2021-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209184-001NP2021-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N209184-001NP2021-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N209184-001NP2021-12-21ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVODOPA42 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2107616Internal RxNorm lookup
2107621Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
077c0f39-a3a2-4b2b-a184-09131889dcfbAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0259-6142-01Inbrija4 in 1 BLISTER PACKCAPSULE41
0259-6142-16Inbrija4 in 1 CARTONCAPSULE41
0259-6142-32Inbrija8 in 1 CARTONCAPSULE81
0259-6142-60Inbrija15 in 1 CARTONCAPSULE151

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InbrijaLEVODOPAMerz Pharmaceuticals, LLC077c0f39-a3a2-4b2b-a184-09131889dcfb2026-07-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 209184
application number: NDA209184
ndc (product): 0259-6142
InbrijaLEVODOPAMerz Pharmaceuticals, LLCa906f8e1-6e1c-480a-8276-c01bc65dd3be2026-01-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 209184
application number: NDA209184

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2107621Inbrija 42 MG Inhalation Powder CapsulePSN077c0f39-a3a2-4b2b-a184-09131889dcfb1
2107616levodopa 42 MG Inhalation Powder CapsulePSN077c0f39-a3a2-4b2b-a184-09131889dcfb1
2107621levodopa 42 MG Inhalation Powder [Inbrija]SBD077c0f39-a3a2-4b2b-a184-09131889dcfb1
2107616levodopa 42 MG Inhalation PowderSCD077c0f39-a3a2-4b2b-a184-09131889dcfb1
2107621Inbrija 42 MG Inhalation PowderSY077c0f39-a3a2-4b2b-a184-09131889dcfb1
2107616L-DOPA 42 MG Inhalation PowderSY077c0f39-a3a2-4b2b-a184-09131889dcfb1
2107621L-DOPA 42 MG Inhalation Powder [Inbrija]SY077c0f39-a3a2-4b2b-a184-09131889dcfb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0259-6142-01002596142014 in 1 BLISTER PACKHistorical
0259-6142-16002596142164 BLISTER PACK in 1 CARTON (0259-6142-16) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01) 4 blister pack2018-12-22YesNoCurrent
0259-6142-32002596142328 BLISTER PACK in 1 CARTON (0259-6142-32) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01) 8 blister pack2018-12-22YesNoCurrent
0259-6142-600025961426015 BLISTER PACK in 1 CARTON (0259-6142-60) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01) 15 blister pack2018-12-22NoNoCurrent