Home NDC 68462-427 Fluticasone Propionate
Product NDC 68462-427
11-digit product format 684620427
Labeler code 68462
Product ID 68462-427_033b2fba-d1e5-4bb5-8b20-005d905056bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluticasone Propionate
Dosage form LOTION
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090759
Marketing category ANDA
Marketing start 2011-10-13
Substance FLUTICASONE PROPIONATE
Active strength .5 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 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 A090759-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02
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 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL 2011-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB 2011-05-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090759-001 FLUTICASONE PROPIONATE 0.05% LOTION / TOPICAL AB RS 2011-05-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fluticasone Propionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUTICASONE PROPIONATE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O2GMZ0LF5W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 895990 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 68462-427-02 Fluticasone Propionate 1 in 1 CARTON LOTION 1 10 68462-427-02 Fluticasone Propionate 60 mL in 1 BOTTLE LOTION 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUTICASONE PROPIONATE ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 ANHYDROUS TRISODIUM CITRATE INACTIVE INGREDIENT RS7A450LGA FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 IMIDUREA INACTIVE INGREDIENT M629807ATL FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 LIGHT MINERAL OIL INACTIVE INGREDIENT N6K5787QVP FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5 WATER INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-427 FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] 10 Current NDC, Legacy NDC, 2 package rows 20240104_3c7b3482-e2fd-4857-9394-a47fd7f4c47b.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 Units Marketing start Marketing end Sample Exclude flag Status 68462-427-02 68462042702 1 BOTTLE in 1 CARTON (68462-427-02) / 60 mL in 1 BOTTLE 1 bottle 2011-10-13 0000-00-00 No No Current