FDA.reportPublic FDA data

Budesonide Inhalation Suspension

Product NDC
76204-018
11-digit product format
762040018
Labeler code
76204
Product ID
76204-018_eff7eb41-672a-5ed3-e053-2a95a90a35d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide Inhalation Suspension
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA210897
Marketing category
ANDA
Marketing start
2021-12-01
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
1 mg/2mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76204-018-012024-01-30C16284748780-11030e365-39b6-111a-e063-dadaa90a10e2Budesonide Inhalation Suspension These highlights do not include all the information needed to use BUDESONIDE INHALATION SUSPENSION safely and effectively. See full prescribing information for BUDESONIDE INHALATION SUSPENSION. BUDESONIDE inhalation suspension. Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-018-01Budesonide Inhalation Suspension1 in 1 CARTONSUSPENSION14
76204-018-11Budesonide Inhalation Suspension5 mL in 1 AMPULESUSPENSION54
76204-018-11Budesonide Inhalation Suspension30 in 1 POUCHSUSPENSION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-018-01ML - Milliliter76204-018db8aa0b8-e9c3-4c26-8a5b-664e5ce0174612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-018BUDESONIDE INHALATION SUSPENSION SUSPENSION [RITEDOSE PHARMACEUTICALS, LLC]4Legacy NDC, 3 package rows20221217_d2178406-9d1b-e0e0-e053-2a95a90a16be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNd2178406-9d1b-e0e0-e053-2a95a90a16be4
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDd2178406-9d1b-e0e0-e053-2a95a90a16be4
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYd2178406-9d1b-e0e0-e053-2a95a90a16be4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76204-018-01762040018011 POUCH in 1 CARTON (76204-018-01) > 30 AMPULE in 1 POUCH (76204-018-11) > 5 mL in 1 AMPULE1 pouch2021-12-010000-00-00NoNoCurrent
76204-018-11762040018115 mL in 1 AMPULE5 mlHistorical