Home NDC 60432-264-15 FLUTICASONE
Product NDC 60432-264
Requested package NDC 60432-264-15
11-digit product format 604320264
Labeler code 60432
Product ID 60432-264_a9e7f8b6-a38a-4128-b1c8-8a008bd15842
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluticasone propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler Morton Grove Pharmaceuticals, Inc.
Application ANDA078492
Marketing category ANDA
Marketing start 2012-01-09
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 60432-264-15 FLUTICASONE 120 in 1 BOTTLE, SPRAY SPRAY, METERED 120 9 60432-264-15 FLUTICASONE 1 in 1 BOX SPRAY, METERED 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluticasone Propionate ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 Fluticasone ACTIVE MOIETY CUT2W21N7U FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 Anhydrous Dextrose INACTIVE INGREDIENT 5SL0G7R0OK FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 Phenylethyl Alcohol INACTIVE INGREDIENT ML9LGA7468 FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 3 FLUTICASONE PROPIONATE ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE SPRAY, METERED [DIRECT RX] 1 FLUTICASONE PROPIONATE ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 1 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 1 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE SPRAY, METERED [DIRECT RX] 1 ANHYDROUS DEXTROSE INACTIVE INGREDIENT 5SL0G7R0OK FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 1 Anhydrous Dextrose INACTIVE INGREDIENT 5SL0G7R0OK FLUTICASONE SPRAY, METERED [DIRECT RX] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 1 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 FLUTICASONE SPRAY, METERED [DIRECT RX] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 1 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 FLUTICASONE SPRAY, METERED [DIRECT RX] 1 PHENYLETHYL ALCOHOL INACTIVE INGREDIENT ML9LGA7468 FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 1 Phenylethyl Alcohol INACTIVE INGREDIENT ML9LGA7468 FLUTICASONE SPRAY, METERED [DIRECT RX] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUTICASONE SPRAY, METERED [DIRECT RX] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MEDSOURCE PHARMACEUTICALS] 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 60432-264 FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [MORTON GROVE PHARMACEUTICALS, INC.] 9 Legacy NDC, 2 package rows 20190207_7c692ed5-959e-4c48-aeec-0799d8979693.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 60432-264-15 60432026415 1 BOTTLE, SPRAY in 1 BOX (60432-264-15) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2012-01-09 0000-00-00 No No Current