Home NDC 64980-124 Diflorasone Diacetate
Product NDC 64980-124
11-digit product format 649800124
Labeler code 64980
Product ID 64980-124_0cc31fd1-b6fb-44d0-a911-b4c11ce12c4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diflorasone diacetate
Dosage form OINTMENT
Route TOPICAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA207440
Marketing category ANDA
Marketing start 2017-02-27
Substance DIFLORASONE DIACETATE
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 A207440-001 DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207440-001 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 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207440-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB 2017-02-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diflorasone Diacetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIFLORASONE DIACETATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7W2J09SCWX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966607 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 64980-124-03 Diflorasone Diacetate 30 g in 1 TUBE OINTMENT 30 4 64980-124-03 Diflorasone Diacetate 1 in 1 CARTON OINTMENT 1 4 64980-124-15 Diflorasone Diacetate 15 g in 1 TUBE OINTMENT 15 4 64980-124-15 Diflorasone Diacetate 1 in 1 CARTON OINTMENT 1 4 64980-124-45 Diflorasone Diacetate 45 g in 1 TUBE OINTMENT 45 4 64980-124-45 Diflorasone Diacetate 1 in 1 CARTON OINTMENT 1 4 64980-124-60 Diflorasone Diacetate 1 in 1 CARTON OINTMENT 1 4 64980-124-60 Diflorasone Diacetate 60 g in 1 TUBE OINTMENT 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-124 DIFLORASONE DIACETATE OINTMENT [RISING PHARMA HOLDINGS, INC.] 4 Current NDC, Legacy NDC, 8 package rows 20230625_23eb27a4-157f-4eb5-a390-37586710808f.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 64980-124-03 64980012403 1 TUBE in 1 CARTON (64980-124-03) / 30 g in 1 TUBE 1 tube 2017-02-27 0000-00-00 No No Current 64980-124-15 64980012415 1 TUBE in 1 CARTON (64980-124-15) / 15 g in 1 TUBE 1 tube 2017-02-27 0000-00-00 No No Current 64980-124-45 64980012445 1 TUBE in 1 CARTON (64980-124-45) / 45 g in 1 TUBE 1 tube 2017-02-27 0000-00-00 No No Current 64980-124-60 64980012460 1 TUBE in 1 CARTON (64980-124-60) / 60 g in 1 TUBE 1 tube 2017-02-27 0000-00-00 No No Current