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

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 Identifiers#

Field, Values table
FieldValues
Unii46627O600J
Rxcui2107616, 2107621

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
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10144-342-01Inbrija4 in 1 BLISTER PACKCAPSULE413
10144-342-04Inbrija1 in 1 CARTONCAPSULE113
10144-342-12Inbrija3 in 1 CARTONCAPSULE313
10144-342-16Inbrija4 in 1 CARTONCAPSULE413
10144-342-32Inbrija8 in 1 CARTONCAPSULE813
10144-342-60Inbrija15 in 1 CARTONCAPSULE1513
10144-342-92Inbrija23 in 1 CARTONCAPSULE2313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10144-342-01EA - Each10144-342891311e2-da25-451d-9f13-84022b85a6a912020-09-14
10144-342-60EA - Each10144-3426ec7e724-881d-44e6-91ae-387df04ead4312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10144-342INBRIJA (LEVODOPA) CAPSULE [MERZ PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 7 package rows20241218_a906f8e1-6e1c-480a-8276-c01bc65dd3be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2107621Inbrija 42 MG Inhalation Powder CapsulePSNa906f8e1-6e1c-480a-8276-c01bc65dd3be13
2107616levodopa 42 MG Inhalation Powder CapsulePSNa906f8e1-6e1c-480a-8276-c01bc65dd3be13
2107621levodopa 42 MG Inhalation Powder [Inbrija]SBDa906f8e1-6e1c-480a-8276-c01bc65dd3be13
2107616levodopa 42 MG Inhalation PowderSCDa906f8e1-6e1c-480a-8276-c01bc65dd3be13
2107621Inbrija 42 MG Inhalation PowderSYa906f8e1-6e1c-480a-8276-c01bc65dd3be13
2107616L-DOPA 42 MG Inhalation PowderSYa906f8e1-6e1c-480a-8276-c01bc65dd3be13
2107621L-DOPA 42 MG Inhalation Powder [Inbrija]SYa906f8e1-6e1c-480a-8276-c01bc65dd3be13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10144-342-01101440342014 in 1 BLISTER PACKHistorical
10144-342-04101440342041 BLISTER PACK in 1 CARTON (10144-342-04) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 1 blister pack2019-08-290000-00-00NoNoCurrent
10144-342-12101440342123 BLISTER PACK in 1 CARTON (10144-342-12) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 3 blister pack2019-08-290000-00-00NoNoCurrent
10144-342-16101440342164 BLISTER PACK in 1 CARTON (10144-342-16) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 4 blister pack2018-12-220000-00-00NoNoCurrent
10144-342-32101440342328 BLISTER PACK in 1 CARTON (10144-342-32) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 8 blister pack2018-12-220000-00-00NoNoCurrent
10144-342-601014403426015 BLISTER PACK in 1 CARTON (10144-342-60) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 15 blister pack2018-12-220000-00-00NoNoCurrent
10144-342-921014403429223 BLISTER PACK in 1 CARTON (10144-342-92) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) 23 blister pack2018-12-220000-00-00NoNoCurrent