FDA.reportPublic FDA data

PULMICORT RESPULES

Product NDC
0186-1990
11-digit product format
001861990
Labeler code
0186
Product ID
0186-1990_76a8044c-b6f4-4da4-b855-a281fdca66b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA020929
Marketing category
NDA
Marketing start
2007-09-17
Substance
BUDESONIDE
Active strength
1 mg/2mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PULMICORT RESPULES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE1 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui252559, 349094, 351109, 616817, 616819, 616830

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0186-1990-04PULMICORT RESPULES5 in 1 POUCHSUSPENSION523
0186-1990-04PULMICORT RESPULES6 in 1 CARTONSUSPENSION623

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0186-1990-04ML - Milliliter0186-1990878795c7-9c77-46ca-b5c1-5b353a119bce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
WATERINACTIVE INGREDIENT059QF0KO0RPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0186-1990PULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA PHARMACEUTICALS LP]23Current NDC, Legacy NDC, 2 package rows20241120_33cd9834-76df-4f26-3fa2-aab6b9eee8f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
252559budesonide 1 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830Pulmicort Respules 0.25 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817Pulmicort Respules 0.5 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819Pulmicort Respules 1 MG in 2 ML Inhalation SuspensionPSN33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830budesonide 0.125 MG/ML Inhalation Suspension [Pulmicort]SBD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817budesonide 0.25 MG/ML Inhalation Suspension [Pulmicort]SBD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819budesonide 0.5 MG/ML Inhalation Suspension [Pulmicort]SBD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
252559budesonide 0.5 MG/ML Inhalation SuspensionSCD33cd9834-76df-4f26-3fa2-aab6b9eee8f223
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
252559budesonide 1 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830Pulmicort Respules 0.125 MG/ACTUAT Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616830Pulmicort Respules 0.25 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817Pulmicort Respules 0.25 MG/ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616817Pulmicort Respules 0.5 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819Pulmicort Respules 0.5 MG/ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223
616819Pulmicort Respules 1 MG per 2 ML Inhalation SuspensionSY33cd9834-76df-4f26-3fa2-aab6b9eee8f223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0186-1990-04001861990046 POUCH in 1 CARTON (0186-1990-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE6 pouch2007-09-170000-00-00NoNoCurrent