FDA.reportPublic FDA data

BREZTRI

Product NDC
0310-4616
11-digit product format
003104616
Labeler code
0310
Product ID
0310-4616_2d00a029-b36a-4a4f-8583-1af78a184682
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide, glycopyrrolate, and formoterol fumarate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA212122
Marketing category
NDA
Marketing start
2020-07-23
Substance
BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE
Active strength
160; 4.8; 9 ug/1; ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [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

Additional Listing Data#

Finished product
Yes
Brand name base
BREZTRI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE160 ug/1
FORMOTEROL4.8 ug/1
GLYCOPYRROLATE9 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5ZZ84GCW8B, V92SO9WP2I, Q3OKS62Q6X
Rxcui2387326, 2387328, 2387329, 2387331, 2741705, 2741708, 2741710, 2741711

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
138c3de2-4b03-4255-92b5-f022482d81bcProduct name420260113
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810eProduct name520250304
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
76dcac30-469f-4f92-9c55-70950d209446Product name120230809
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
132196a6-5117-4b6e-a9dd-27f2793580c6Product name120230112
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
ac1f888b-a1db-4d2e-abbc-973f21c2ce1bProduct name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
d84dd569-7bf0-1410-25eb-017ef37dd406Product name920210902
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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
58b12de9-b891-41c7-9be6-ff47de5ec28bProduct name120180828
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
9aff7b10-8e47-4b10-9a92-803440a37ce2Product name120180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75aProduct name120151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6Product name120151109
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106
29ae08d1-069f-9822-4820-152d5dc67797Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-4616-12BREZTRI120 in 1 INHALERAEROSOL, METERED1207
0310-4616-28BREZTRI28 in 1 INHALERAEROSOL, METERED287
0310-4616-39BREZTRI28 in 1 INHALERAEROSOL, METERED287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-4616-12GM - Gram0310-461682127501-61a2-446a-93a2-b44360a1ea7212020-08-06
0310-4616-28GM - Gram0310-4616f9bce7a1-ffac-4b63-82af-30ac7975e93a12021-06-02
0310-4616-39GM - Gram0310-46168502c568-739a-4296-91d2-01f736457c2412020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-4616BREZTRI (BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP]5Current NDC, Legacy NDC, 3 package rows20241013_715433dc-cb2b-43ea-b6df-c5b4177adc6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741711BREZTRI 160/18/4.8 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741708BREZTRI 160/18/4.8 MCG/INHAL Metered Dose Inhaler, 28 ActuationsPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387328BREZTRI 160/9/4.8 MCG INHAL Metered Dose Inhaler, 28 ActuationsPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387331BREZTRI 160/9/4.8 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387329budesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT 120 ACTUAT Metered Dose InhalerPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387326budesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT 28 ACTUAT Metered Dose InhalerPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741710budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 120 ACTUAT Metered Dose InhalerPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741705budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 28 ACTUAT Metered Dose InhalerPSN715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387331120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri]SBD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741711120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler [Breztri]SBD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
238732828 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri]SBD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
274170828 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler [Breztri]SBD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387329120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose InhalerSCD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741710120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose InhalerSCD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
238732628 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose InhalerSCD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
274170528 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose InhalerSCD715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387331BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUATSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387328BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 28 ACTUATSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741711BREZTRI (budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUATSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741708BREZTRI (budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT) Metered Dose Inhaler, 28 ACTUATSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387329budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 120 ACTUAT Metered Dose InhalerSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2387326budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose InhalerSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741710budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 120 ACTUAT Metered Dose InhalerSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7
2741705budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 28 ACTUAT Metered Dose InhalerSY715433dc-cb2b-43ea-b6df-c5b4177adc6c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-4616-1200310461612120 AEROSOL, METERED in 1 INHALER (0310-4616-12) 2020-07-230000-00-00NoNoCurrent
0310-4616-280031046162828 AEROSOL, METERED in 1 INHALER (0310-4616-28) 2020-07-230000-00-00YesNoCurrent
0310-4616-390031046163928 AEROSOL, METERED in 1 INHALER (0310-4616-39) 2020-07-230000-00-00NoNoCurrent