Arnuity Ellipta

Product NDC
0173-0874
11-digit product format
001730874
Labeler code
0173
Product ID
0173-0874_99087493-3503-425e-91e3-ba430d16104f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone furoate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA205625
Marketing category
NDA
Marketing start
2014-08-20
Substance
FLUTICASONE FUROATE
Active strength
100 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205625-001ARNUITY ELLIPTAFLUTICASONE FUROATE0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20
N205625-002ARNUITY ELLIPTAFLUTICASONE FUROATE0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20
N205625-003ARNUITY ELLIPTAFLUTICASONE FUROATE0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N205625-003M-2902026-03-01

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20caaa826d4ba7…
2026-08-18 06:07:402026-07N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20caaa826d4ba7…
2026-08-18 06:07:402026-07N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-201e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 20 · 780 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00193333102027-10-02Drug product2016-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-0019333310*PED2028-04-02Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00182015562029-02-05Drug product2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00187462422030-10-11Drug product2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-0018746242*PED2031-04-11Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00293333102027-10-02Drug product2016-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-0029333310*PED2028-04-02Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00282015562029-02-05Drug product2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00287462422030-10-11Drug product2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-0028746242*PED2031-04-11Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00393333102027-10-02Drug product2018-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-0039333310*PED2028-04-02Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00382015562029-02-05Drug product2018-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-00387462422030-10-11Drug product2018-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-0038746242*PED2031-04-11Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00193333102027-10-02Drug product2016-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-0019333310*PED2028-04-02Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00182015562029-02-05Drug product2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00187462422030-10-11Drug product2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-0018746242*PED2031-04-11Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00293333102027-10-02Drug product2016-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-0029333310*PED2028-04-02Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00282015562029-02-05Drug product2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00287462422030-10-11Drug product2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-0028746242*PED2031-04-11Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00393333102027-10-02Drug product2018-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-0039333310*PED2028-04-02Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00382015562029-02-05Drug product2018-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-00387462422030-10-11Drug product2018-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-0038746242*PED2031-04-11Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-00193333102027-10-02Drug product2016-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-0019333310*PED2028-04-02Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-00182015562029-02-05Drug product2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-00187462422030-10-11Drug product2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-0018746242*PED2031-04-11Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-00293333102027-10-02Drug product2016-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-0029333310*PED2028-04-02Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-00282015562029-02-05Drug product2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-00287462422030-10-11Drug product2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-0028746242*PED2031-04-11Pediatric extension03ed91905a0d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N205625-003M-2902026-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205625-003M-2902026-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205625-003M-2902026-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205625-003M-2902026-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205625-003M-2902026-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205625-003M-2902026-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205625-003M-2902026-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205625-003M-2902026-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205625-003M-2902026-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205625-003M-2902026-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205625-003M-2902026-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205625-003M-2902026-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205625-003M-2902026-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205625-003M-2902026-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205625-003M-2902026-03-018072bd15b7f6…
2019-12-13 00:20 UTC2019-12N205625-001NPP2021-05-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205625-003NS2021-05-1774a2ff9319b5…
2021-12-28 21:50 UTC2021-12N205625-001NPP2021-05-17782e0a99824c…
2021-12-28 21:50 UTC2021-12N205625-003NS2021-05-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205625-001NPP2021-05-1787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205625-003NS2021-05-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N205625-001NPP2021-05-175aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N205625-003NS2021-05-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205625-001NPP2021-05-178869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205625-003NS2021-05-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205625-001NPP2021-05-17c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205625-003NS2021-05-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205625-001NPP2021-05-173f01610625f2…
2019-12-14 00:12 UTC2019-12N205625-003NS2021-05-173f01610625f2…
2019-09-15 20:21 UTC2019-09N205625-001NPP2021-05-17b00525d2431f…
2019-09-15 20:21 UTC2019-09N205625-003NS2021-05-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N205625-001NPP2021-05-17ea99ee380514…
2019-07-19 19:46 UTC2019-07N205625-003NS2021-05-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205625-003M-2902026-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205625-003M-2902026-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205625-003M-2902026-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205625-003M-2902026-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205625-003M-2902026-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205625-003M-2902026-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205625-003M-2902026-03-013f0d92c62455…

Additional Listing Data#

Finished product
Yes
Brand name base
Arnuity Ellipta
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE100 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JS86977WNVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1547658Internal RxNorm lookup
1547660Internal RxNorm lookup
1547663Internal RxNorm lookup
1547664Internal RxNorm lookup
1547666Internal RxNorm lookup
1547668Internal RxNorm lookup
1547671Internal RxNorm lookup
1547672Internal RxNorm lookup
2045377Internal RxNorm lookup
2045382Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50f193ee-1691-486d-9370-a664df63695cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0874-10Arnuity Ellipta30 in 1 INHALERPOWDER3017
0173-0874-10Arnuity Ellipta1 in 1 CARTONPOWDER117
0173-0874-14Arnuity Ellipta14 in 1 INHALERPOWDER1417
0173-0874-14Arnuity Ellipta1 in 1 CARTONPOWDER117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0874-10EA - Each0173-0874ae8203f9-a7ff-4d5b-99f3-5dbc78a62b1e12015-01-05
0173-0874-14EA - Each0173-0874c495ecb0-7765-472c-bb36-dff8d80f769512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE FUROATEACTIVE INGREDIENTJS86977WNVARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]4
FLUTICASONEACTIVE MOIETYCUT2W21N7UARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0874ARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]16Current NDC, Legacy NDC, 4 package rows20240308_50f193ee-1691-486d-9370-a664df63695c.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone Furoate ElliptaFLUTICASONE FUROATEPrasco Laboratoriesd3e797fc-2636-49a0-b89e-5246b18ee4402025-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 205625
application number: NDA205625
Arnuity ElliptaFLUTICASONE FUROATEGlaxoSmithKline LLC50f193ee-1691-486d-9370-a664df63695c2023-10-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 205625
application number: NDA205625
ndc (product): 0173-0874

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547664ARNUITY ELLIPTA 100 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547660ARNUITY ELLIPTA 100 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547668ARNUITY ELLIPTA 200 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547672ARNUITY ELLIPTA 200 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
2045382Arnuity Ellipta 50 MCG/ACTUAT Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547663fluticasone furoate 100 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547658fluticasone furoate 100 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547666fluticasone furoate 200 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547671fluticasone furoate 200 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
2045377fluticasone furoate 50 MCG/ACTUAT Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
154766414 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154766814 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
204538230 ACTUAT fluticasone furoate 0.05 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154766030 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154767230 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154766314 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154766614 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
204537730 ACTUAT fluticasone furoate 0.05 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154765830 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154767130 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154766814 ACTUAT Arnuity 0.2 MG/ACTUAT Dry Powder InhalerSY50f193ee-1691-486d-9370-a664df63695c17
204538230 ACTUAT Arnuity 0.05 MG/ACTUAT Dry Powder InhalerSY50f193ee-1691-486d-9370-a664df63695c17
1547664Arnuity 0.1 MG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547660Arnuity 100 MCG/INHAL Dry Powder Inhaler, 30 BlistersSY50f193ee-1691-486d-9370-a664df63695c17
1547664Arnuity Ellipta 100 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547672Arnuity Ellipta 200 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547663fluticasone furoate 100 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547658fluticasone furoate 100 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547666fluticasone furoate 200 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547671fluticasone furoate 200 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
2045377fluticasone furoate 50 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0874-10001730874101 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER1 inhaler2014-08-200000-00-00NoNoCurrent
0173-0874-14001730874141 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER1 inhaler2014-08-200000-00-00NoNoCurrent
0173-0874-61001730874611 INHALER in 1 CARTON (0173-0874-61) > 14 POWDER in 1 INHALER1 inhaler2014-08-200000-00-00NoNoCurrent