Home NDC 68788-9925-1 Fluticasone Propionate
Product NDC 68788-9925
Requested package NDC 68788-9925-1
11-digit product format 687889925
Labeler code 68788
Product ID 68788-9925_afad29a8-4b27-4344-8891-f567ddea9934
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluticasone Propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA077570
Marketing category ANDA
Marketing start 2012-01-18
Marketing end 0000-00-00
Substance FLUTICASONE PROPIONATE
Active strength 50 ug/.1g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 84e616aacf4f…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…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 68788-9925-1 Fluticasone Propionate 1 in 1 CARTON SPRAY, METERED 1 6 68788-9925-1 Fluticasone Propionate 16 g in 1 BOTTLE, PUMP SPRAY, METERED 16 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUTICASONE PROPIONATE ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 PHENYLETHYL ALCOHOL INACTIVE INGREDIENT ML9LGA7468 FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9925 FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.] 6 Legacy NDC, 2 package rows 20210514_3e710670-b72c-4a84-8c52-3ebae8783a32.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-9925-1 68788992501 1 BOTTLE, PUMP in 1 CARTON (68788-9925-1) > 16 g in 1 BOTTLE, PUMP 2012-01-18 0000-00-00 No No Current