SYMBICORT

Product NDC: 0186-0372
11-digit product format: 001860372
Labeler code: 0186
Product ID: 0186-0372_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: 80; 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
Ingredient	Strength
BUDESONIDE	80 ug/1
FORMOTEROL FUMARATE	4.5 ug/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	Q3OKS62Q6X, W34SHF8J2K
Rxcui	1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367	Product name	4	20250303
7816cdf6-b925-4282-bedd-11ae25d518a1	Product name	1	20250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d	Product name	2	20240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
218c043e-94e5-4e66-a363-d0d446485bc6	Product name	2	20210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7	Product name	9	20210127
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
58f15a44-d9d2-4d61-a39d-7f0223302a8f	Product name	1	20190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0186-0372-20	SYMBICORT	1 in 1 POUCH	AEROSOL	1	31
0186-0372-20	SYMBICORT	1 in 1 CARTON	AEROSOL	1	31
0186-0372-28	SYMBICORT	1 in 1 CARTON	AEROSOL	1	31
0186-0372-28	SYMBICORT	1 in 1 POUCH	AEROSOL	1	31
0186-0372-60	SYMBICORT	1 in 1 CARTON	AEROSOL	1	31
0186-0372-60	SYMBICORT	1 in 1 POUCH	AEROSOL	1	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0186-0372-20	GM - Gram	0186-0372	77ea8c50-a43d-453b-beb8-e579af944665	1	2012-07-24
0186-0372-28	GM - Gram	0186-0372	3da0edac-521e-49ec-878c-f80b52a803ff	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]	14
FORMOTEROL FUMARATE	ACTIVE INGREDIENT	W34SHF8J2K	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]	14
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]	14
FORMOTEROL	ACTIVE MOIETY	5ZZ84GCW8B	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]	14
APAFLURANE	INACTIVE INGREDIENT	R40P36GDK6	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]	14
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0186-0372	SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA PHARMACEUTICALS LP]	31	Current NDC, Legacy NDC, 6 package rows	20241120_fafa4cf1-99c2-43d5-73ad-51f256de3be0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE
W34SHF8J2K	FORMOTEROL FUMARATE	183814-30-4	FORMOTEROL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246304	budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246316	budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246288	budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246314	budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246306	Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246317	Symbicort 160/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246290	Symbicort 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246315	Symbicort 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246290	120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]	SBD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246306	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]	SBD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246315	60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]	SBD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246317	60 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]	SBD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246288	120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246304	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246314	60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246316	60 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246288	budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246314	budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246304	budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246316	budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246304	budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246316	budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246288	budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246314	budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246306	Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246317	Symbicort 160/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246306	Symbicort 160/4.5 Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246317	Symbicort 160/4.5 Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246290	Symbicort 80/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246315	Symbicort 80/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246290	Symbicort 80/4.5 Metered Dose Inhaler, 120 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246315	Symbicort 80/4.5 Metered Dose Inhaler, 60 ACTUAT	SY	fafa4cf1-99c2-43d5-73ad-51f256de3be0	31
1246314	budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246315	Symbicort 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246315	60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]	SBD	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246314	60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246314	budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246314	budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246315	Symbicort 80/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 60 ACTUAT	SY	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246315	Symbicort 80/4.5 Metered Dose Inhaler, 60 ACTUAT	SY	52f45e18-463e-4ce3-8ccd-c0260473e6b5	8
1246314	budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	a645756c-c692-4bc6-a858-7e7e249561bd	1
1246315	Symbicort 80/4.5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	a645756c-c692-4bc6-a858-7e7e249561bd	1
1246315	60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Symbicort]	SBD	a645756c-c692-4bc6-a858-7e7e249561bd	1
1246314	60 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	a645756c-c692-4bc6-a858-7e7e249561bd	1
1246314	budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	a645756c-c692-4bc6-a858-7e7e249561bd	1
1246314	budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	a645756c-c692-4bc6-a858-7e7e249561bd	1
1246315	Symbicort 80/4.5 (budesonide / formoterol fumarate) Metered Dose Inhaler, 60 ACTUAT	SY	a645756c-c692-4bc6-a858-7e7e249561bd	1
1246315	Symbicort 80/4.5 Metered Dose Inhaler, 60 ACTUAT	SY	a645756c-c692-4bc6-a858-7e7e249561bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0186-0372-20	00186037220	1 POUCH in 1 CARTON (0186-0372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER	1 pouch	2007-05-29	0000-00-00	No	No	Current
0186-0372-28	00186037228	1 POUCH in 1 CARTON (0186-0372-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER	1 pouch	2007-09-06	0000-00-00	No	No	Current
0186-0372-60	00186037260	1 POUCH in 1 CARTON (0186-0372-60) > 1 CANISTER in 1 POUCH > 60 AEROSOL in 1 CANISTER	1 pouch	2007-09-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SYMBICORT - Sportpharm LLC	Sportpharm LLC	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	1
SYMBICORT - A-S Medication Solutions	A-S Medication Solutions	2024-04-15	HUMAN PRESCRIPTION DRUG LABEL	8
SYMBICORT - AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2019-07-24	HUMAN PRESCRIPTION DRUG LABEL	31

SYMBICORT

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#