FDA.reportPublic FDA data

SYMBICORT

Product NDC
0186-0370
11-digit product format
001860370
Labeler code
0186
Product ID
0186-0370_1f05ded1-7d31-4cfc-8537-0e75f99ad452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide and Formoterol Fumarate Dihydrate
Dosage form
AEROSOL
Route
RESPIRATORY (INHALATION)
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA021929
Marketing category
NDA
Marketing start
2007-05-29
Substance
BUDESONIDE; FORMOTEROL FUMARATE
Active strength
160; 4.5 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE160 ug/1
FORMOTEROL FUMARATE4.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X, W34SHF8J2K
Rxcui1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
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
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0186-0370-20SYMBICORT1 in 1 CARTONAEROSOL131
0186-0370-20SYMBICORT1 in 1 POUCHAEROSOL131
0186-0370-28SYMBICORT1 in 1 CARTONAEROSOL131
0186-0370-28SYMBICORT1 in 1 POUCHAEROSOL131
0186-0370-60SYMBICORT1 in 1 CARTONAEROSOL131
0186-0370-60SYMBICORT1 in 1 POUCHAEROSOL131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0186-0370-20GM - Gram0186-0370fc0e8741-b1ce-40ce-bbeb-25c5f24d240c12012-07-24
0186-0370-28GM - Gram0186-0370b5090ed6-a293-40bd-8f13-fb9e82b0889012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XSYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
FORMOTEROL FUMARATEACTIVE INGREDIENTW34SHF8J2KSYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XSYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
FORMOTEROLACTIVE MOIETY5ZZ84GCW8BSYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
APAFLURANEINACTIVE INGREDIENTR40P36GDK6SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0186-0370SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA PHARMACEUTICALS LP]31Current NDC, Legacy NDC, 6 package rows20241120_fafa4cf1-99c2-43d5-73ad-51f256de3be0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246304budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246316budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246288budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246314budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246306Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246317Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246290Symbicort 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246315Symbicort 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246290120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]SBDfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246306120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]SBDfafa4cf1-99c2-43d5-73ad-51f256de3be031
124631560 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]SBDfafa4cf1-99c2-43d5-73ad-51f256de3be031
124631760 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]SBDfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246288120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246304120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDfafa4cf1-99c2-43d5-73ad-51f256de3be031
124631460 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDfafa4cf1-99c2-43d5-73ad-51f256de3be031
124631660 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246288budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246314budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246304budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246316budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246304budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246316budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246288budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246314budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246306Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246317Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246306Symbicort 160/4.5 Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246317Symbicort 160/4.5 Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246290Symbicort 80/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246315Symbicort 80/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246290Symbicort 80/4.5 Metered Dose Inhaler, 120 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246315Symbicort 80/4.5 Metered Dose Inhaler, 60 ACTUATSYfafa4cf1-99c2-43d5-73ad-51f256de3be031
1246304budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246306Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246306120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]SBD6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246304120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCD6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246304budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246304budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246306Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUATSY6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246306Symbicort 160/4.5 Metered Dose Inhaler, 120 ACTUATSY6b78d08a-e098-4188-8f7f-94fbd5f396ef15
1246304budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246306Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246306120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]SBD5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246304120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCD5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246304budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246304budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246306Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUATSY5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246306Symbicort 160/4.5 Metered Dose Inhaler, 120 ACTUATSY5feb8f35-b237-477a-9836-2a6db2ed6fa711
1246304budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN805764a1-65e1-4117-ac4a-7a54c3986cfe8
1246306Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN805764a1-65e1-4117-ac4a-7a54c3986cfe8
1246306120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]SBD805764a1-65e1-4117-ac4a-7a54c3986cfe8
1246304120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCD805764a1-65e1-4117-ac4a-7a54c3986cfe8
1246304budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY805764a1-65e1-4117-ac4a-7a54c3986cfe8
1246304budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY805764a1-65e1-4117-ac4a-7a54c3986cfe8
1246306Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUATSY805764a1-65e1-4117-ac4a-7a54c3986cfe8
1246306Symbicort 160/4.5 Metered Dose Inhaler, 120 ACTUATSY805764a1-65e1-4117-ac4a-7a54c3986cfe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0186-0370-20001860370201 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER1 pouch2007-05-290000-00-00NoNoCurrent
0186-0370-28001860370281 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER1 pouch2007-09-060000-00-00NoNoCurrent
0186-0370-60001860370601 POUCH in 1 CARTON (0186-0370-60) > 1 CANISTER in 1 POUCH > 60 AEROSOL in 1 CANISTER1 pouch2007-09-060000-00-00NoNoCurrent