FDA.reportPublic FDA data

Budesonide and formoterol fumarate dihydrate

Product NDC
0480-3081
11-digit product format
004803081
Labeler code
0480
Product ID
0480-3081_3dc30116-6267-434d-bfef-24a1dcb253db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide and formoterol fumarate dihydrate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA212212
Marketing category
ANDA
Marketing start
2026-05-27
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212212-001BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE0.08MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-23
A212212-002BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEBUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE0.16MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212212-001AB
A212212-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212212-001BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE0.08MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-2384e616aacf4f…
2026-09-14 22:38:342026-08A212212-002BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE0.16MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-2384e616aacf4f…
2026-08-18 06:07:402026-07A212212-001BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE0.08MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A212212-002BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE0.16MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-23caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212212-001BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE0.08MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212212-002BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE0.16MG/INH;0.0045MG/INHAEROSOL, METERED / INHALATIONAB2026-04-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212212-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212212-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A212212-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212212-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212212-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212212-002AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Budesonide and formoterol fumarate dihydrate
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3OKS62Q6XInternal UNII lookup
W34SHF8J2KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246288Internal RxNorm lookup
1246304Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd352302-e2fe-4388-b4b0-00b34f6ebe48Available on FDA.report

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
0480-3081-31Budesonide and formoterol fumarate dihydrate1 in 1 POUCHAEROSOL, METERED12
0480-3081-31Budesonide and formoterol fumarate dihydrate1 in 1 CARTONAEROSOL, METERED12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Budesonide and formoterol fumarate dihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATETeva Pharmaceuticals, Inc.dd352302-e2fe-4388-b4b0-00b34f6ebe482022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212212
application number: ANDA212212
ndc (product): 0480-3081

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246304budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdd352302-e2fe-4388-b4b0-00b34f6ebe482
1246288budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdd352302-e2fe-4388-b4b0-00b34f6ebe482
1246288120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDdd352302-e2fe-4388-b4b0-00b34f6ebe482
1246304120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose InhalerSCDdd352302-e2fe-4388-b4b0-00b34f6ebe482
1246288budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdd352302-e2fe-4388-b4b0-00b34f6ebe482
1246304budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdd352302-e2fe-4388-b4b0-00b34f6ebe482
1246304budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdd352302-e2fe-4388-b4b0-00b34f6ebe482
1246288budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdd352302-e2fe-4388-b4b0-00b34f6ebe482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-3081-31004803081311 POUCH in 1 CARTON (0480-3081-31) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER1 pouch2026-05-27NoNoCurrent