ADVAIR

Product NDC
0173-0697
11-digit product format
001730697
Labeler code
0173
Product ID
0173-0697_0add9a7a-38ae-489a-9635-7b85c20ba985
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA021077
Marketing category
NDA
Marketing start
2001-03-05
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
500; 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0173-06970173-0697-04DDiscontinued by firm2026-08-17

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
N021077-001ADVAIR DISKUS 100/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24
N021077-002ADVAIR DISKUS 250/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24
N021077-003ADVAIR DISKUS 500/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021077-001AB
N021077-002AB
N021077-003AB

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 06:07:402026-07N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021077-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021077-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021077-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021077-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021077-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021077-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-001AB11e350fbaab3a…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021077-001M-2142020-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021077-002M-2142020-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021077-003M-2142020-12-2074a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021077-001M-2142020-12-208869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021077-002M-2142020-12-208869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021077-003M-2142020-12-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021077-001M-2142020-12-20c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021077-002M-2142020-12-20c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021077-003M-2142020-12-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021077-001M-2142020-12-203f01610625f2…
2019-12-14 00:12 UTC2019-12N021077-002M-2142020-12-203f01610625f2…
2019-12-14 00:12 UTC2019-12N021077-003M-2142020-12-203f01610625f2…
2019-09-15 20:21 UTC2019-09N021077-001M-2142020-12-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N021077-002M-2142020-12-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N021077-003M-2142020-12-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N021077-001M-2142020-12-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N021077-002M-2142020-12-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N021077-003M-2142020-12-20ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
ADVAIR
Brand name suffix
DISKUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALMETEROL XINAFOATE500 ug/1
FLUTICASONE PROPIONATE50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6EW8Q962A5Internal UNII lookup
O2GMZ0LF5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896161Internal RxNorm lookup
896165Internal RxNorm lookup
896184Internal RxNorm lookup
896185Internal RxNorm lookup
896186Internal RxNorm lookup
896190Internal RxNorm lookup
896209Internal RxNorm lookup
896212Internal RxNorm lookup
896218Internal RxNorm lookup
896222Internal RxNorm lookup
896228Internal RxNorm lookup
896229Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4eeb5f6a-593f-4a9e-9692-adefa2caf8fcAvailable 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
811691fa-281f-6d95-fb49-e2337fb2e146Product 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
0173-0697-00ADVAIRDISKUS60 in 1 INHALERPOWDER6032
0173-0697-00ADVAIRDISKUS1 in 1 CARTONPOWDER132
0173-0697-04ADVAIRDISKUS14 in 1 INHALERPOWDER1432
0173-0697-04ADVAIRDISKUS1 in 1 CARTONPOWDER132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0697-00EA - Each0173-0697bbcdca61-4809-4a23-bea5-b5bd90edfac612012-07-24
0173-0697-04EA - Each0173-0697729aeb5d-0895-4fb4-b61a-2071e0c2452712012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0697ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [GLAXOSMITHKLINE LLC]30Current NDC, Legacy NDC, 4 package rows20240625_4eeb5f6a-593f-4a9e-9692-adefa2caf8fc.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutionscf306656-0d4c-4edd-9d6a-3471f99484e62026-04-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLGlaxoSmithKline LLC4eeb5f6a-593f-4a9e-9692-adefa2caf8fc2026-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 0173-0697
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.0a2d1344-f412-41db-9b54-0c92a07437032026-02-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions17dd0a86-8161-4aa9-9b90-a23d81b381642025-08-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.197b7628-71aa-4fa2-94df-d617c0f2c9862025-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.1ce604aa-2535-4a3c-a64d-092f5d4f81942025-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions7c9c722b-68ac-4bda-ad99-50e3fb1c58c82024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions9e237635-6975-4930-9ce1-051d9e3bf6152024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLPrasco Laboratories6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc2023-07-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutionsa6d87760-4744-41d5-bfee-db3b996b72942023-05-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions2dfadeac-6599-41c5-8e25-5f78cba17f002023-02-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutionsccf98c0a-fc40-4e08-bdf2-145fe4537db52023-02-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLProficient Rx LP6915bd5d-b792-4b1b-8221-7eeb0a8638ba2020-01-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896185ADVAIR DISKUS 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896212ADVAIR DISKUS 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896229ADVAIR DISKUS 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896184fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896228fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
89618560 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBDcf306656-0d4c-4edd-9d6a-3471f99484e637
89621260 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBDcf306656-0d4c-4edd-9d6a-3471f99484e637
89622960 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBDcf306656-0d4c-4edd-9d6a-3471f99484e637
89618460 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCDcf306656-0d4c-4edd-9d6a-3471f99484e637
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCDcf306656-0d4c-4edd-9d6a-3471f99484e637
89622860 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCDcf306656-0d4c-4edd-9d6a-3471f99484e637
896185Advair Diskus 100/50 (fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896185Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896212Advair Diskus 250/50 (fluticasone propionate 250 MCG / salmeterol 50 MCG (as salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896212Advair Diskus 250/50 Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896229Advair Diskus 500/50 (fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896229Advair Diskus 500/50 Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896184fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896228fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896184fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896228fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896165ADVAIR DISKUS 100/50 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896185ADVAIR DISKUS 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896190ADVAIR DISKUS 250/50 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896212ADVAIR DISKUS 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896222ADVAIR DISKUS 500/50 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896229ADVAIR DISKUS 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896161fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896184fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896186fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896218fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896228fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89616514 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89619014 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89622214 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89618560 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89621260 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89622960 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89616114 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89618614 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89621814 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89618460 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
89622860 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896165Advair Diskus 100/50 (fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896185Advair Diskus 100/50 (fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896165Advair Diskus 100/50 Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896185Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896212Advair Diskus 250/50 (fluticasone propionate 250 MCG / salmeterol 50 MCG (as salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896190Advair Diskus 250/50 (fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896190Advair Diskus 250/50 Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896212Advair Diskus 250/50 Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896222Advair Diskus 500/50 (fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896229Advair Diskus 500/50 (fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896222Advair Diskus 500/50 Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896229Advair Diskus 500/50 Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896161fluticasone propionate 0.1 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896184fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896218fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896228fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896161fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896184fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896218fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 14 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896228fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY4eeb5f6a-593f-4a9e-9692-adefa2caf8fc32
896229ADVAIR DISKUS 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN17dd0a86-8161-4aa9-9b90-a23d81b3816410
896228fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN17dd0a86-8161-4aa9-9b90-a23d81b3816410
89622960 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD17dd0a86-8161-4aa9-9b90-a23d81b3816410
89622860 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD17dd0a86-8161-4aa9-9b90-a23d81b3816410
896229Advair Diskus 500/50 (fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY17dd0a86-8161-4aa9-9b90-a23d81b3816410
896229Advair Diskus 500/50 Dry Powder Inhaler, 60 ACTUATSY17dd0a86-8161-4aa9-9b90-a23d81b3816410
896228fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY17dd0a86-8161-4aa9-9b90-a23d81b3816410
896228fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY17dd0a86-8161-4aa9-9b90-a23d81b3816410
896185ADVAIR DISKUS 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNb20c1d84-5c49-47de-bd2e-f987ff67faef1
896212ADVAIR DISKUS 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNb20c1d84-5c49-47de-bd2e-f987ff67faef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0697-00001730697001 INHALER in 1 CARTON (0173-0697-00) / 60 POWDER in 1 INHALER1 inhaler2001-03-050000-00-00NoNoCurrent
0173-0697-04001730697041 INHALER in 1 CARTON (0173-0697-04) > 14 POWDER in 1 INHALER1 inhaler2001-03-050000-00-00NoNoCurrent