Home NDC 0173-0521 SEREVENT
Product NDC 0173-0521
11-digit product format 001730521
Labeler code 0173
Product ID 0173-0521_5532804f-f5b5-492b-a092-0b1ce60c8de1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name salmeterol xinafoate
Dosage form POWDER, METERED
Route ORAL; RESPIRATORY (INHALATION)
Labeler GlaxoSmithKline LLC
Application NDA020692
Marketing category NDA
Marketing start 1997-11-25
Substance SALMETEROL XINAFOATE
Active strength 50 ug/1
Pharmacologic classes Adrenergic beta2-Agonists [MoA], 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020692-001 SEREVENT SALMETEROL XINAFOATE EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020692-001 SEREVENT EQ 0.05MG BASE/INH POWDER / INHALATION RLD, RS 1997-09-19 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base SEREVENT
Brand name suffix DISKUS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALMETEROL XINAFOATE 50 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 866048 Internal RxNorm lookup 866049 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 0173-0521-00 SEREVENTDISKUS 1 in 1 CARTON POWDER, METERED 1 31 0173-0521-00 SEREVENTDISKUS 60 in 1 INHALER POWDER, METERED 60 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SALMETEROL XINAFOATE ACTIVE INGREDIENT 6EW8Q962A5 SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [GLAXOSMITHKLINE LLC] 17 SALMETEROL ACTIVE MOIETY 2I4BC502BT SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [GLAXOSMITHKLINE LLC] 17 LACTOSE INACTIVE INGREDIENT J2B2A4N98G SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [GLAXOSMITHKLINE LLC] 17 SALMETEROL XINAFOATE ACTIVE INGREDIENT 6EW8Q962A5 SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.] 2 SALMETEROL ACTIVE MOIETY 2I4BC502BT SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0521 SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [GLAXOSMITHKLINE LLC] 30 Current NDC, Legacy NDC, 2 package rows 20241204_12d9728e-6b5c-4aee-bfb0-745e542ed2e4.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 · 1 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 866048 salmeterol 50 MCG/INHAL Dry Powder Inhaler, 60 Bisters PSN 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 31 866049 Serevent Diskus 50 MCG/INHAL Dry Powder Inhaler, 60 Blisters PSN 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 31 866049 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Serevent] SBD 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 31 866048 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler SCD 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 31 866049 60 ACTUAT Serevent 0.05 MG/ACTUAT Dry Powder Inhaler SY 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 31 866048 salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 Actuat SY 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 31 866049 Serevent Diskus 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 31 866048 salmeterol 50 MCG/INHAL Dry Powder Inhaler, 60 Bisters PSN c4925b2c-bde1-45fd-8109-dc75bee3b7a3 2 866049 Serevent Diskus 50 MCG/INHAL Dry Powder Inhaler, 60 Blisters PSN c4925b2c-bde1-45fd-8109-dc75bee3b7a3 2 866049 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Serevent] SBD c4925b2c-bde1-45fd-8109-dc75bee3b7a3 2 866048 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler SCD c4925b2c-bde1-45fd-8109-dc75bee3b7a3 2 866049 60 ACTUAT Serevent 0.05 MG/ACTUAT Dry Powder Inhaler SY c4925b2c-bde1-45fd-8109-dc75bee3b7a3 2 866048 salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 Actuat SY c4925b2c-bde1-45fd-8109-dc75bee3b7a3 2 866049 Serevent Diskus 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT SY c4925b2c-bde1-45fd-8109-dc75bee3b7a3 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0173-0521-00 00173052100 1 INHALER in 1 CARTON (0173-0521-00) / 60 POWDER, METERED in 1 INHALER 1 inhaler 1997-11-25 0000-00-00 No No Current