diflorasone diacetate

Generic: diflorasone diacetate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diflorasone diacetate
Generic Name diflorasone diacetate
Labeler rising pharma holdings, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

diflorasone diacetate .5 mg/g

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-124
Product ID 64980-124_0cc31fd1-b6fb-44d0-a911-b4c11ce12c4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207440
Listing Expiration 2026-12-31
Marketing Start 2017-02-27

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980124
Hyphenated Format 64980-124

Supplemental Identifiers

RxCUI
966607
UNII
7W2J09SCWX

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diflorasone diacetate (source: ndc)
Generic Name diflorasone diacetate (source: ndc)
Application Number ANDA207440 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (64980-124-03) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (64980-124-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (64980-124-45) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (64980-124-60) / 60 g in 1 TUBE
source: ndc

Packages (4)

64980-124-03 1 TUBE in 1 CARTON (64980-124-03) / 30 g in 1 TUBE 64980-124-15 1 TUBE in 1 CARTON (64980-124-15) / 15 g in 1 TUBE 64980-124-45 1 TUBE in 1 CARTON (64980-124-45) / 45 g in 1 TUBE 64980-124-60 1 TUBE in 1 CARTON (64980-124-60) / 60 g in 1 TUBE

Ingredients (1)

diflorasone diacetate (.5 mg/g)

Linked Drug Pages (1)

Diflorasone Diacetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0cc31fd1-b6fb-44d0-a911-b4c11ce12c4b", "openfda": {"unii": ["7W2J09SCWX"], "rxcui": ["966607"], "spl_set_id": ["23eb27a4-157f-4eb5-a390-37586710808f"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (64980-124-03)  / 30 g in 1 TUBE", "package_ndc": "64980-124-03", "marketing_start_date": "20170227"}, {"sample": false, "description": "1 TUBE in 1 CARTON (64980-124-15)  / 15 g in 1 TUBE", "package_ndc": "64980-124-15", "marketing_start_date": "20170227"}, {"sample": false, "description": "1 TUBE in 1 CARTON (64980-124-45)  / 45 g in 1 TUBE", "package_ndc": "64980-124-45", "marketing_start_date": "20170227"}, {"sample": false, "description": "1 TUBE in 1 CARTON (64980-124-60)  / 60 g in 1 TUBE", "package_ndc": "64980-124-60", "marketing_start_date": "20170227"}], "brand_name": "Diflorasone Diacetate", "product_id": "64980-124_0cc31fd1-b6fb-44d0-a911-b4c11ce12c4b", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64980-124", "generic_name": "diflorasone diacetate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diflorasone Diacetate", "active_ingredients": [{"name": "DIFLORASONE DIACETATE", "strength": ".5 mg/g"}], "application_number": "ANDA207440", "marketing_category": "ANDA", "marketing_start_date": "20170227", "listing_expiration_date": "20261231"}