Home NDC 0310-4616 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212122-001 BREZTRI AEROSPHERE BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE 0.16MG/INH;0.0048MG/INH;0.009MG/INH AEROSOL, METERED / INHALATION RLD, RS 2020-07-23 N212122-002 BREZTRI AEROSPHERE BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE 0.16MG/INH;0.0048MG/INH;0.018MG/INH AEROSOL, METERED / INHALATION RLD, RS 2026-04-27
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212122-001 10716753 2030-05-28 U-2889 Drug product 2020-08-18 N212122-001 8324266 2030-05-28 U-2889 2020-08-18 N212122-001 8703806 2030-05-28 U-2889 2020-08-18 N212122-001 8808713 2030-05-28 U-2889 Drug product 2020-08-18 N212122-001 9415009 2030-05-28 U-2889 2020-08-18 N212122-001 9463161 2030-05-28 U-2889 Drug product 2020-08-18 N212122-001 8815258 2031-03-17 U-2889 2020-08-18 N212122-001 11331442 2038-10-05 Drug product 2022-06-16 N212122-001 11833292 2038-10-05 Drug product 2023-12-21 N212122-002 10716753 2030-05-28 U-4503 Drug product 2026-05-19 N212122-002 8324266 2030-05-28 U-4503 2026-05-19 N212122-002 8703806 2030-05-28 U-4503 2026-05-19 N212122-002 8808713 2030-05-28 U-4503 Drug product 2026-05-19 N212122-002 9415009 2030-05-28 U-4503 2026-05-19 N212122-002 9463161 2030-05-28 U-4503 Drug product 2026-05-19 N212122-002 8815258 2031-03-17 U-4503 2026-05-19 N212122-002 11331442 2038-10-05 Drug product 2026-05-19 N212122-002 11833292 2038-10-05 Drug product 2026-05-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212122-002 NS 2029-04-27
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N212122-001 BREZTRI AEROSPHERE 0.16MG/INH;0.0048MG/INH;0.009MG/INH AEROSOL, METERED / INHALATION RLD, RS 2020-07-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 BREZTRI AEROSPHERE 0.16MG/INH;0.0048MG/INH;0.018MG/INH AEROSOL, METERED / INHALATION RLD, RS 2026-04-27 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N212122-001 10716753 2030-05-28 U-2889 Drug product 2020-08-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 8324266 2030-05-28 U-2889 2020-08-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 8703806 2030-05-28 U-2889 2020-08-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 8808713 2030-05-28 U-2889 Drug product 2020-08-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 9415009 2030-05-28 U-2889 2020-08-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 9463161 2030-05-28 U-2889 Drug product 2020-08-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 8815258 2031-03-17 U-2889 2020-08-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 11331442 2038-10-05 Drug product 2022-06-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-001 11833292 2038-10-05 Drug product 2023-12-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 10716753 2030-05-28 U-4503 Drug product 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 8324266 2030-05-28 U-4503 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 8703806 2030-05-28 U-4503 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 8808713 2030-05-28 U-4503 Drug product 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 9415009 2030-05-28 U-4503 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 9463161 2030-05-28 U-4503 Drug product 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 8815258 2031-03-17 U-4503 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 11331442 2038-10-05 Drug product 2026-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N212122-002 11833292 2038-10-05 Drug product 2026-05-19 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N212122-002 NS 2029-04-27 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BREZTRI BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE AstraZeneca Pharmaceuticals LP 715433dc-cb2b-43ea-b6df-c5b4177adc6c 2026-04-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 212122 application number: NDA212122 ndc (product): 0310-4616
Additional Listing Data#
Finished product Yes
Brand name base BREZTRI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE 160 ug/1 GLYCOPYRROLATE 4.8 ug/1 FORMOTEROL 9 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5ZZ84GCW8B Internal UNII lookup Q3OKS62Q6X Internal UNII lookup V92SO9WP2I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387326 Internal RxNorm lookup 2387328 Internal RxNorm lookup 2387329 Internal RxNorm lookup 2387331 Internal RxNorm lookup 2741705 Internal RxNorm lookup 2741708 Internal RxNorm lookup 2741710 Internal RxNorm lookup 2741711 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-4616-12 BREZTRI 120 in 1 INHALER AEROSOL, METERED 120 7 0310-4616-28 BREZTRI 28 in 1 INHALER AEROSOL, METERED 28 7 0310-4616-39 BREZTRI 28 in 1 INHALER AEROSOL, METERED 28 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-4616 BREZTRI (BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP] 5 Current NDC, Legacy NDC, 3 package rows 20241013_715433dc-cb2b-43ea-b6df-c5b4177adc6c.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2741711 BREZTRI 160/18/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741708 BREZTRI 160/18/4.8 MCG/INHAL Metered Dose Inhaler, 28 Actuations PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387328 BREZTRI 160/9/4.8 MCG INHAL Metered Dose Inhaler, 28 Actuations PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387331 BREZTRI 160/9/4.8 MCG/INHAL Metered Dose Inhaler, 120 Actuations PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387329 budesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT 120 ACTUAT Metered Dose Inhaler PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387326 budesonide 0.16 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741710 budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 120 ACTUAT Metered Dose Inhaler PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741705 budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 28 ACTUAT Metered Dose Inhaler PSN 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387331 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri] SBD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741711 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler [Breztri] SBD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387328 28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler [Breztri] SBD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741708 28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler [Breztri] SBD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387329 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler SCD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741710 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler SCD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387326 28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler SCD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741705 28 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.018 MG/ACTUAT Metered Dose Inhaler SCD 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387331 BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387328 BREZTRI (budesonide 160 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT / glycopyrrolate 9 MCG/ACTUAT) Metered Dose Inhaler, 28 ACTUAT SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741711 BREZTRI (budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT) Metered Dose Inhaler, 120 ACTUAT SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741708 BREZTRI (budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT) Metered Dose Inhaler, 28 ACTUAT SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387329 budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 120 ACTUAT Metered Dose Inhaler SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2387326 budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT 28 ACTUAT Metered Dose Inhaler SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741710 budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 120 ACTUAT Metered Dose Inhaler SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7 2741705 budesonide 160 MCG/ACTUAT / glycopyrrolate 18 MCG/ACTUAT / formoterol fumarate 4.8 MCG/ACTUAT 28 ACTUAT Metered Dose Inhaler SY 715433dc-cb2b-43ea-b6df-c5b4177adc6c 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0310-4616-12 00310461612 120 AEROSOL, METERED in 1 INHALER (0310-4616-12) 2020-07-23 0000-00-00 No No Current 0310-4616-28 00310461628 28 AEROSOL, METERED in 1 INHALER (0310-4616-28) 2020-07-23 0000-00-00 Yes No Current 0310-4616-39 00310461639 28 AEROSOL, METERED in 1 INHALER (0310-4616-39) 2020-07-23 0000-00-00 No No Current