Home NDC 10144-342 Inbrija
Product NDC 10144-342
11-digit product format 101440342
Labeler code 10144
Product ID 10144-342_03ec2066-f288-45cb-9919-c49fe175d8ca
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209184-001 INBRIJA LEVODOPA 42MG POWDER / INHALATION RLD, RS 2018-12-21
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 N209184-001 12458615 2033-10-21 U-2484 2025-11-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N209184-001 12458615 2033-10-21 U-2484 2025-11-26 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Inbrija
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVODOPA 42 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 46627O600J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2107616 Internal RxNorm lookup 2107621 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10144-342 INBRIJA (LEVODOPA) CAPSULE [MERZ PHARMACEUTICALS, LLC] 12 Current NDC, Legacy NDC, 7 package rows 20241218_a906f8e1-6e1c-480a-8276-c01bc65dd3be.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10144-342-01 10144034201 4 in 1 BLISTER PACK Historical 10144-342-04 10144034204 1 BLISTER PACK in 1 CARTON (10144-342-04) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 1 blister pack 2019-08-29 0000-00-00 No No Current 10144-342-12 10144034212 3 BLISTER PACK in 1 CARTON (10144-342-12) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 3 blister pack 2019-08-29 0000-00-00 No No Current 10144-342-16 10144034216 4 BLISTER PACK in 1 CARTON (10144-342-16) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 4 blister pack 2018-12-22 0000-00-00 No No Current 10144-342-32 10144034232 8 BLISTER PACK in 1 CARTON (10144-342-32) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 8 blister pack 2018-12-22 0000-00-00 No No Current 10144-342-60 10144034260 15 BLISTER PACK in 1 CARTON (10144-342-60) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 15 blister pack 2018-12-22 0000-00-00 No No Current 10144-342-92 10144034292 23 BLISTER PACK in 1 CARTON (10144-342-92) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 23 blister pack 2018-12-22 0000-00-00 No No Current