Home NDC 63187-021 Fluticasone Propionate
Product NDC 63187-021
11-digit product format 631870021
Labeler code 63187
Product ID 63187-021_82b45510-bf4d-4f1a-bba7-8caeedd68d84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluticasone Propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler Proficient Rx LP
Application ANDA077570
Marketing category ANDA
Marketing start 2008-01-16
Marketing end 0000-00-00
Substance FLUTICASONE PROPIONATE
Active strength 50 ug/.1g
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 63187-021 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-021 63187-021-16 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077570-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16
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 · 42 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 2026-08-18 06:07:40 2026-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUTICASONE PROPIONATE ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 PHENYLETHYL ALCOHOL INACTIVE INGREDIENT ML9LGA7468 FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-021 FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP] 4 Legacy NDC 20221202_a37ccef8-18e8-4194-9618-1b5657ade6ca.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-021-16 63187002116 1 BOTTLE, PUMP in 1 CARTON (63187-021-16) > 16 g in 1 BOTTLE, PUMP 2018-11-01 0000-00-00 No No Current