Home NDC 0713-0631 Fluticasone Propionate
Product NDC 0713-0631
11-digit product format 007130631
Labeler code 0713
Product ID 0713-0631_de485a69-2992-143b-e053-2a95a90a4b89
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluticasone Propionate
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA077055
Marketing category ANDA
Marketing start 2006-06-30
Substance FLUTICASONE PROPIONATE
Active strength .5 mg/g
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 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 A077055-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077055-001 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.
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 2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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/g
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 895987 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 0713-0631-15 Fluticasone Propionate 1 in 1 CARTON CREAM 1 11 0713-0631-15 Fluticasone Propionate 15 g in 1 TUBE CREAM 15 11 0713-0631-31 Fluticasone Propionate 1 in 1 CARTON CREAM 1 11 0713-0631-31 Fluticasone Propionate 30 g in 1 TUBE CREAM 30 11 0713-0631-60 Fluticasone Propionate 60 g in 1 TUBE CREAM 60 11 0713-0631-60 Fluticasone Propionate 1 in 1 CARTON CREAM 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluticasone Propionate ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Fluticasone ACTIVE MOIETY CUT2W21N7U FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Ceteth-20 INACTIVE INGREDIENT I835H2IHHX FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Sodium Phosphate, Dibasic INACTIVE INGREDIENT GR686LBA74 FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Water INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Fluticasone Propionate ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Ceteth-20 INACTIVE INGREDIENT I835H2IHHX FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Sodium Phosphate, Dibasic INACTIVE INGREDIENT GR686LBA74 FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Water INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0631 FLUTICASONE PROPIONATE CREAM [COSETTE PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 6 package rows 20220616_14c8d082-b301-8f09-a509-950459ae0a28.zip
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 0713-0631-15 00713063115 1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBE 1 tube 2006-06-30 0000-00-00 No No Current 0713-0631-31 00713063131 1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBE 1 tube 2006-06-30 0000-00-00 No No Current 0713-0631-60 00713063160 1 TUBE in 1 CARTON (0713-0631-60) / 60 g in 1 TUBE 1 tube 2006-06-30 0000-00-00 No No Current