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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209184-001 INBRIJA 42MG POWDER / INHALATION RLD, RS 2018-12-21 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 10 · 395 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209184-001 12458615 2033-10-21 U-2484 2025-11-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209184-001 12458615 2033-10-21 U-2484 2025-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209184-001 7182961 2024-02-22 Drug product 2019-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209184-001 8545878 2032-11-16 Drug product 2019-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209184-001 8685442 2032-11-16 Drug product 2019-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209184-001 8945612 2032-11-16 Drug product 2019-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209184-001 9393210 2032-11-16 Drug product 2019-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209184-001 7182961 2024-02-22 Drug product 2019-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209184-001 RE43711 2029-02-03 U-2484 2019-01-18 2680178bc6a6…
Observed Orange Book exclusivity history# 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
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.
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