Home NDC 0378-9320 Wixela Inhub
Product NDC 0378-9320
11-digit product format 003789320
Labeler code 0378
Product ID 0378-9320_03d33612-03b4-4a2c-ba86-47816db363ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluticasone propionate and salmeterol
Dosage form POWDER
Route RESPIRATORY (INHALATION)
Labeler Mylan Pharmaceuticals Inc.
Application ANDA208891
Marketing category ANDA
Marketing start 2019-02-11
Substance FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength 100; 50 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208891-001 WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 A208891-002 WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 A208891-003 WIXELA INHUB FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 4 · 129 observed 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 2026-09-14 22:38:34 2026-08 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208891-002 WIXELA INHUB 0.25MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208891-003 WIXELA INHUB 0.5MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208891-001 WIXELA INHUB 0.1MG/INH;EQ 0.05MG BASE/INH POWDER / INHALATION AB 2019-01-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 Wixela Inhub
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUTICASONE PROPIONATE 100 ug/1 SALMETEROL XINAFOATE 50 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O2GMZ0LF5W Internal UNII lookup 6EW8Q962A5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896184 Internal RxNorm lookup 896209 Internal RxNorm lookup 896228 Internal RxNorm lookup 2110510 Internal RxNorm lookup 2110513 Internal RxNorm lookup 2110516 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 0378-9320-32 Wixela Inhub 60 in 1 INHALER POWDER 60 6 0378-9320-32 Wixela Inhub 1 in 1 CARTON POWDER 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-9320 WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [MYLAN PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 2 package rows 20220911_3beef422-8a07-4a45-9ba6-414511e4b7e2.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 896184 fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters PSN 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896209 fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters PSN 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896228 fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters PSN 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110510 Wixela Inhub 100/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations PSN 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110513 Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations PSN 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110516 Wixela Inhub 500/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations PSN 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110510 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela] SBD 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110513 60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela] SBD 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110516 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela] SBD 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896184 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler SCD 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896209 60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler SCD 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896228 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler SCD 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896184 fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896209 fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896228 fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896184 fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896209 fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 896228 fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110510 Wixela Inhub 100/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110513 Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6 2110516 Wixela Inhub 500/50 MCG/INHAL Dry Powder Inhaler, 60 Actuations SY 3beef422-8a07-4a45-9ba6-414511e4b7e2 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-9320-32 00378932032 1 INHALER in 1 CARTON (0378-9320-32) / 60 POWDER in 1 INHALER 1 inhaler 2019-02-11 0000-00-00 No No Current