FDA.reportPublic FDA data

Budesonide

Product NDC
0093-6815
11-digit product format
000936815
Labeler code
0093
Product ID
0093-6815_551a929a-3517-4e58-9df6-f9bfb0f2f3be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077519
Marketing category
ANDA
Marketing start
2019-01-11
Substance
BUDESONIDE
Active strength
.25 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
Budesonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE.25 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui349094, 351109

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-6815-19Budesonide2 mL in 1 VIAL, SINGLE-DOSESUSPENSION213
0093-6815-45Budesonide5 in 1 POUCHSUSPENSION513
0093-6815-73Budesonide6 in 1 CARTONSUSPENSION613
0093-6815-76Budesonide5 in 1 POUCHSUSPENSION513
0093-6815-76Budesonide2 in 1 CARTONSUSPENSION213
0093-6815-55Budesonide30 in 1 CARTONSUSPENSION304
0093-6815-55Budesonide1 in 1 POUCHSUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-6815-19ML - Milliliter0093-681533bd9aec-ae08-45ba-a170-1356a2d307eb12019-02-13
0093-6815-45ML - Milliliter0093-68156c917816-229f-4e31-870d-6708593d39be12012-07-24
0093-6815-55ML - Milliliter0093-68152347f550-303c-46d1-b6f2-77f0ec5e41e512019-02-13
0093-6815-73ML - Milliliter0093-68155d67e6fd-36fb-452c-94cd-666ced2eb81c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
WATERINACTIVE INGREDIENT059QF0KO0RBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBUDESONIDE SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-6815BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 5 package rows20210626_2414058b-5d39-42f2-915f-03a5e1101ab5.zip
0093-6815BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 2 package rows20210626_4f126a29-38f7-4c4c-8978-37e72b289902.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN2414058b-5d39-42f2-915f-03a5e1101ab513
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN2414058b-5d39-42f2-915f-03a5e1101ab513
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD2414058b-5d39-42f2-915f-03a5e1101ab513
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD2414058b-5d39-42f2-915f-03a5e1101ab513
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY2414058b-5d39-42f2-915f-03a5e1101ab513
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY2414058b-5d39-42f2-915f-03a5e1101ab513
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN4f126a29-38f7-4c4c-8978-37e72b2899024
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN4f126a29-38f7-4c4c-8978-37e72b2899024
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD4f126a29-38f7-4c4c-8978-37e72b2899024
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD4f126a29-38f7-4c4c-8978-37e72b2899024
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY4f126a29-38f7-4c4c-8978-37e72b2899024
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY4f126a29-38f7-4c4c-8978-37e72b2899024
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN32e30f11-e19b-4e23-a893-92d95e48edef2
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNca6ae964-3b4b-4c24-a939-0100791ce1fe2
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNca6ae964-3b4b-4c24-a939-0100791ce1fe2
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD32e30f11-e19b-4e23-a893-92d95e48edef2
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDca6ae964-3b4b-4c24-a939-0100791ce1fe2
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDca6ae964-3b4b-4c24-a939-0100791ce1fe2
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY32e30f11-e19b-4e23-a893-92d95e48edef2
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYca6ae964-3b4b-4c24-a939-0100791ce1fe2
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYca6ae964-3b4b-4c24-a939-0100791ce1fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-6815-19000936815192 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0093-6815-45000936815455 in 1 POUCHHistorical
0093-6815-550009368155530 POUCH in 1 CARTON (0093-6815-55) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2019-01-110000-00-00NoNoCurrent
0093-6815-73000936815736 POUCH in 1 CARTON (0093-6815-73) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-6815-45) / 2 mL in 1 VIAL, SINGLE-DOSE (0093-6815-19) 6 pouch2008-11-190000-00-00NoNoCurrent
0093-6815-76000936815762 POUCH in 1 CARTON (0093-6815-76) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE2 pouch2008-11-190000-00-00NoNoCurrent