FDA.reportPublic FDA data

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 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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N209184-001INBRIJA42MGPOWDER / INHALATIONRLD, RS2018-12-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N209184-001RE437112029-02-03U-24842019-01-18a50c72e98297…
2026-08-01 22:54:322026-06N209184-00185458782032-11-16Drug product2019-01-18a50c72e98297…
2026-08-01 22:54:322026-06N209184-00186854422032-11-16Drug product2019-01-18a50c72e98297…
2026-08-01 22:54:322026-06N209184-00189456122032-11-16Drug product2019-01-18a50c72e98297…
2026-08-01 22:54:322026-06N209184-00193932102032-11-16Drug product2019-01-18a50c72e98297…
2026-08-01 22:54:322026-06N209184-001124586152033-10-21U-24842025-11-26a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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