Home NDC 59310-200-06 ArmonAir Digihaler
Product NDC 59310-200
Requested package NDC 59310-200-06
11-digit product format 593100200
Labeler code 59310
Product ID 59310-200_8fd236af-c81c-46e9-819e-b37891da2662
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluticasone Propionate
Dosage form POWDER, METERED
Route RESPIRATORY (INHALATION)
Labeler Teva Respiratory, LLC
Application NDA208798
Marketing category NDA
Marketing start 2020-09-15
Marketing end 0000-00-00
Substance FLUTICASONE PROPIONATE
Active strength 113 ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208798-001 ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 0.055MG/INH POWDER / INHALATION RLD 2017-01-27 N208798-002 ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 0.113MG/INH POWDER / INHALATION RLD 2017-01-27 N208798-003 ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 0.232MG/INH POWDER / INHALATION RLD 2017-01-27 N208798-004 ARMONAIR DIGIHALER FLUTICASONE PROPIONATE 0.055MG/INH POWDER / INHALATION RLD 2020-02-20 N208798-005 ARMONAIR DIGIHALER FLUTICASONE PROPIONATE 0.113MG/INH POWDER / INHALATION RLD 2020-02-20 N208798-006 ARMONAIR DIGIHALER FLUTICASONE PROPIONATE 0.232MG/INH POWDER / INHALATION RLD 2020-02-20 N208798-007 ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 0.03MG/INH POWDER / INHALATION RLD 2021-07-09 N208798-008 ARMONAIR DIGIHALER FLUTICASONE PROPIONATE 0.03MG/INH POWDER / INHALATION RLD 2022-04-08
Orange Book patents# Current patent rows page 1 of 1 · 56 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 8 · 312 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 N208798-001 ARMONAIR RESPICLICK 0.055MG/INH POWDER / INHALATION RLD 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-002 ARMONAIR RESPICLICK 0.113MG/INH POWDER / INHALATION RLD 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-003 ARMONAIR RESPICLICK 0.232MG/INH POWDER / INHALATION RLD 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 ARMONAIR DIGIHALER 0.055MG/INH POWDER / INHALATION RLD 2020-02-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 ARMONAIR DIGIHALER 0.113MG/INH POWDER / INHALATION RLD 2020-02-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 ARMONAIR DIGIHALER 0.232MG/INH POWDER / INHALATION RLD 2020-02-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-007 ARMONAIR RESPICLICK 0.03MG/INH POWDER / INHALATION RLD 2021-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-008 ARMONAIR DIGIHALER 0.03MG/INH POWDER / INHALATION RLD 2022-04-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208798-001 ARMONAIR RESPICLICK 0.055MG/INH POWDER / INHALATION RLD 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208798-002 ARMONAIR RESPICLICK 0.113MG/INH POWDER / INHALATION RLD 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208798-003 ARMONAIR RESPICLICK 0.232MG/INH POWDER / INHALATION RLD 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208798-004 ARMONAIR DIGIHALER 0.055MG/INH POWDER / INHALATION RLD 2020-02-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208798-005 ARMONAIR DIGIHALER 0.113MG/INH POWDER / INHALATION RLD 2020-02-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208798-006 ARMONAIR DIGIHALER 0.232MG/INH POWDER / INHALATION RLD 2020-02-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208798-007 ARMONAIR RESPICLICK 0.03MG/INH POWDER / INHALATION RLD 2021-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208798-008 ARMONAIR DIGIHALER 0.03MG/INH POWDER / INHALATION RLD 2022-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208798-001 ARMONAIR RESPICLICK 0.055MG/INH POWDER / INHALATION RLD 2017-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208798-002 ARMONAIR RESPICLICK 0.113MG/INH POWDER / INHALATION RLD 2017-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208798-003 ARMONAIR RESPICLICK 0.232MG/INH POWDER / INHALATION RLD 2017-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208798-004 ARMONAIR DIGIHALER 0.055MG/INH POWDER / INHALATION RLD 2020-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208798-005 ARMONAIR DIGIHALER 0.113MG/INH POWDER / INHALATION RLD 2020-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208798-006 ARMONAIR DIGIHALER 0.232MG/INH POWDER / INHALATION RLD 2020-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208798-007 ARMONAIR RESPICLICK 0.03MG/INH POWDER / INHALATION RLD 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208798-008 ARMONAIR DIGIHALER 0.03MG/INH POWDER / INHALATION RLD 2022-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-001 ARMONAIR RESPICLICK 0.055MG/INH POWDER / INHALATION RLD 2017-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-002 ARMONAIR RESPICLICK 0.113MG/INH POWDER / INHALATION RLD 2017-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-003 ARMONAIR RESPICLICK 0.232MG/INH POWDER / INHALATION RLD 2017-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-004 ARMONAIR DIGIHALER 0.055MG/INH POWDER / INHALATION RLD 2020-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-005 ARMONAIR DIGIHALER 0.113MG/INH POWDER / INHALATION RLD 2020-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-006 ARMONAIR DIGIHALER 0.232MG/INH POWDER / INHALATION RLD 2020-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-007 ARMONAIR RESPICLICK 0.03MG/INH POWDER / INHALATION RLD 2021-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208798-008 ARMONAIR DIGIHALER 0.03MG/INH POWDER / INHALATION RLD 2022-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208798-001 ARMONAIR RESPICLICK 0.055MG/INH POWDER / INHALATION RLD 2017-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208798-002 ARMONAIR RESPICLICK 0.113MG/INH POWDER / INHALATION RLD 2017-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208798-003 ARMONAIR RESPICLICK 0.232MG/INH POWDER / INHALATION RLD 2017-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208798-004 ARMONAIR DIGIHALER 0.055MG/INH POWDER / INHALATION RLD 2020-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208798-005 ARMONAIR DIGIHALER 0.113MG/INH POWDER / INHALATION RLD 2020-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208798-006 ARMONAIR DIGIHALER 0.232MG/INH POWDER / INHALATION RLD 2020-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208798-007 ARMONAIR RESPICLICK 0.03MG/INH POWDER / INHALATION RLD 2021-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208798-008 ARMONAIR DIGIHALER 0.03MG/INH POWDER / INHALATION RLD 2022-04-08 6a471c1ec25d…
Observed Orange Book patent history# Patent history page 1 of 239 · 9,521 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208798-001 10195375 2031-02-14 Drug product 2019-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-001 10195375*PED 2031-08-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-001 11969544 2039-08-20 Drug product 2024-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-001 11969544*PED 2040-02-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-002 10195375 2031-02-14 Drug product 2019-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-002 10195375*PED 2031-08-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-002 11969544 2039-08-20 Drug product 2024-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-002 11969544*PED 2040-02-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-003 10195375 2031-02-14 Drug product 2019-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-003 10195375*PED 2031-08-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-003 11969544 2039-08-20 Drug product 2024-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-003 11969544*PED 2040-02-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 10195375 2031-02-14 Drug product 2020-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 10195375*PED 2031-08-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 10918816 2035-12-14 Drug product 2021-03-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 10918816*PED 2036-06-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 11969544 2039-08-20 Drug product 2024-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 11344685 2039-09-26 Drug product 2022-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 11969544*PED 2040-02-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 11344685*PED 2040-03-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 11173259 2040-07-06 Drug product 2021-12-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-004 11173259*PED 2041-01-06 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 10195375 2031-02-14 Drug product 2020-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 10195375*PED 2031-08-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 10918816 2035-12-14 Drug product 2021-03-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 10918816*PED 2036-06-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 11969544 2039-08-20 Drug product 2024-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 11344685 2039-09-26 Drug product 2022-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 11969544*PED 2040-02-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 11344685*PED 2040-03-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 11173259 2040-07-06 Drug product 2021-12-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-005 11173259*PED 2041-01-06 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 10195375 2031-02-14 Drug product 2020-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 10195375*PED 2031-08-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 10918816 2035-12-14 Drug product 2021-03-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 10918816*PED 2036-06-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 11969544 2039-08-20 Drug product 2024-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 11344685 2039-09-26 Drug product 2022-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 11969544*PED 2040-02-20 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208798-006 11344685*PED 2040-03-26 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 204 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59310-200 ARMONAIR DIGIHALER (FLUTICASONE PROPIONATE) POWDER, METERED ARMONAIR DIGIHALER (FLUTICASONE PROPIONATE) POWDER, METERED [TEVA RESPIRATORY, LLC] 12 Legacy NDC 20240515_5cea205f-e6d4-45e8-bfcc-a12a6907d5bb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59310-200-06 59310020006 1 POUCH in 1 CARTON (59310-200-06) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER 1 pouch 2020-09-15 0000-00-00 No No Current