NDC 78206-118-01 Celestone Soluspan

Betamethasone Acetate And Betamethasone Sodium Phosphate

  1. Labeler Index
  2. Organon Llc
  3. 78206-118
  4. NDC Package Code: 78206-118-01 Celestone Soluspan

NDC Package Code 78206-118-01

The NDC Code 78206-118-01 is assigned to a package of 1 vial, multi-dose in 1 box > 5 ml in 1 vial, multi-dose of Celestone Soluspan, a human prescription drug labeled by Organon Llc. The product's dosage form is injection, suspension and is administered via intra-articular; intralesional; intramuscular; soft tissue form.

The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 78206-118-01 is $7.19000 and is up-to-date as of 12-15-2021.

Field Name Field Value
NDC Code 78206-118-01
Package Description 1 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE
Proprietary Name Celestone Soluspan What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Betamethasone Acetate And Betamethasone Sodium Phosphate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 78206011801 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk578803 and 578806 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Organon Llc
Dosage Form Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s)
  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Soft Tissue - Administration into any soft tissue.
Active Ingredient(s)
  • BETAMETHASONE ACETATE 3 mg/mL
  • BETAMETHASONE SODIUM PHOSPHATE 3 mg/mL
Pharmacological Class(es)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NDA014602 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 06-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 78206 - Organon Llc
    • 78206-118 - Celestone Soluspan
      • 78206-118-01 - 1 VIAL, MULTI-DOSE in 1 BOX

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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National Average Drug Acquisition Cost (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

Field Name Field Value
Price per Unit $7.19000
Effective Date 09-15-2021 Effective Date
The effective date of the NADAC Per Unit cost.
Pricing Unit ML Pricing Unit
Indicates the pricing unit for the associated NDC (ML, GM or EA).
Pharmacy Type Indicator C/I - Chain or Independent Pharmacy Pharmacy Type Indicator
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Explanation Code Code 4: The NADAC was carried forward from the previous file.
Code 5: The NADAC was calculated based on package size. Explanation Code
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Classification for Rate Setting B - Brand Classification for Rate Setting
Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
Corresponding Generic Drug NADAC Per Unit 8.93160 Corresponding Generic Drug NADAC Per Unit
The NADAC for the corresponding generic drug.
Corresponding Generic Drug Effective Date 09/15/2021 Corresponding Generic Drug Effective Date
The effective date of when the Corresponding Generic Drug NADAC Per Unit is assigned to a multiple source brand drug NDC. This date may not correspond to the NADAC effective date for the generic drug due to the method by which the corresponding generic drug NADAC effective date is assigned.
As of Date 12-15-2021
View Pricing Details

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 78206-118-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
78206011801J0702Betamethasone acet&sod phosp3 MG & 3 MG5155

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