Home NDC 63629-4989 Wixela Inhub
Product NDC 63629-4989
11-digit product format 636294989
Labeler code 63629
Product ID 63629-4989_391adc06-fb77-4a41-83c1-5ac4a9ffae3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluticasone propionate and salmeterol
Dosage form POWDER
Route RESPIRATORY (INHALATION)
Labeler Bryant Ranch Prepack
Application ANDA208891
Marketing category ANDA
Marketing start 2019-02-11
Substance FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength 250; 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 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUTICASONE PROPIONATE 250 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896209 Internal RxNorm lookup 2110513 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 63629-4989-1 Wixela Inhub 60 in 1 INHALER POWDER 60 100 63629-4989-1 Wixela Inhub 1 in 1 CARTON POWDER 1 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-4989 WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [BRYANT RANCH PREPACK] 100 Current NDC, 2 package rows 20250215_6a5e28ef-3bbb-43a6-b599-499b3c6076c9.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63629-4989-1 63629498901 1 INHALER in 1 CARTON (63629-4989-1) / 60 POWDER in 1 INHALER 1 inhaler 2025-02-13 No No Current