Home NDC 61919-004 FLUTICASONE
Product NDC 61919-004
11-digit product format 619190004
Labeler code 61919
Product ID 61919-004_861d65c9-fb38-b548-e053-2a91aa0a2366
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUTICASONE
Dosage form SPRAY, METERED
Route NASAL
Labeler Direct RX
Application ANDA078492
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 0000-00-00
Substance FLUTICASONE PROPIONATE
Active strength 50 ug/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-004-16 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-004-16 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-004-16 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-004-16 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-004-16 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-004-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-004-16 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-004-16 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-004-16 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A078492-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078492-001 AB
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 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078492-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2012-01-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-004-16 FLUTICASONE 1 in 1 BOX SPRAY, METERED 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUTICASONE PROPIONATE ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE SPRAY, METERED [DIRECT RX] 1 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE SPRAY, METERED [DIRECT RX] 1 Anhydrous Dextrose INACTIVE INGREDIENT 5SL0G7R0OK FLUTICASONE SPRAY, METERED [DIRECT RX] 1 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 FLUTICASONE SPRAY, METERED [DIRECT RX] 1 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 FLUTICASONE SPRAY, METERED [DIRECT RX] 1 Phenylethyl Alcohol INACTIVE INGREDIENT ML9LGA7468 FLUTICASONE SPRAY, METERED [DIRECT RX] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUTICASONE SPRAY, METERED [DIRECT RX] 1 Water INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE SPRAY, METERED [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-004 FLUTICASONE SPRAY, METERED [DIRECT RX] 4 Legacy NDC, 1 package rows 20190410_ab7529ac-fa19-4be8-9906-8889fa3e8398.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61919-004-16 61919000416 1 SPRAY, METERED in 1 BOX (61919-004-16) 2014-12-10 0000-00-00 No No Current