Corticosteroid, beta2-Adrenergic Agonist
Where is Fluticasone and Salmeterol made?
8 companies sell it under their own name and 10 repackagers rebottle it. Their labels name 3 factories in the United States.
United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.50 ug / 100 ug, 50 ug / 250 ug, 50 ug / 500 ug · NDC 69097-662, 69097-661, 69097-663 | InvaGen Pharmaceuticals, IncMakes it | Hauppauge, NY, United States | No problems foundOct 2023 |
| InvaGen Pharmaceuticals, IncMakes it | Central Islip, NY, United States | Problems found, fixed voluntarilyJul 2026 | |
| Hikma Pharmaceuticals USA Inc.50 ug / 100 ug, 50 ug / 250 ug, 50 ug / 500 ug · NDC 0054-0326, 0054-0327, 0054-0328 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| GlaxoSmithKline LLC Advair Hfa, Advairdiskus21 ug / 115 ug, 21 ug / 230 ug, 21 ug / 45 ug, 50 ug / 100 ug, 50 ug / 250 ug, 50 ug / 500 ug · NDC 0173-0716, 0173-0717, 0173-0715 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.50 ug / 100 ug, 50 ug / 250 ug · NDC 0527-6010, 0527-6011 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.50 ug / 100 ug, 50 ug / 250 ug, 50 ug / 500 ug · NDC 0378-9320, 0378-9321, 0378-9322 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories21 ug / 115 ug, 21 ug / 230 ug, 21 ug / 45 ug, 50 ug / 100 ug, 50 ug / 250 ug, 50 ug / 500 ug · NDC 66993-087, 66993-088, 66993-086 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.14 ug / 113 ug, 14 ug / 232 ug, 14 ug / 55 ug, 50 ug / 100 ug, 50 ug / 250 ug, 50 ug / 500 ug · NDC 0093-3608, 0093-3609, 0093-3607 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Respiratory, LLC AirDuo RespiClick14 ug / 113 ug, 14 ug / 232 ug, 14 ug / 55 ug · NDC 59310-812, 59310-822, 59310-805 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluticasone and Salmeterol in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-3271,50090-3387,50090-3272,50090-4504+10 - Aidarex Pharmaceuticals LLC:
33261-873,33261-874 - Bryant Ranch Prepack:
63629-8809,63629-8810,63629-8811,63629-4989 - Dispensing Solutions Inc.:
68258-3031 - Physicians Total Care, Inc.:
54868-4518,54868-4517,54868-4516 - Preferred Pharmaceuticals, Inc..:
68788-8704,68788-8453 - Proficient Rx LP:
71205-262 - RPK Pharmaceuticals, Inc.:
53002-1568 - Rebel Distributors Corp..:
21695-361,21695-196,21695-197 - Remedyrepack Inc.:
70518-4406,70518-4346,70518-3968,70518-4347+1
Recalls
- Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - Oct 24, 2012 · Class III · GlaxoSmithKline, LLC. · 2 recall notices
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.