Prescription drug · NDA
Diprolene (Betamethasone dipropionate) NDC 78206-124
Betamethasone dipropionate .5 mg/g · Ointment · Topical · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-124-01 | 7820601240178206012401 | 1 TUBE in 1 BOX (78206-124-01) / 15 g in 1 TUBEMarketed from Jun 1, 2021 | |
| 78206-124-02 | 7820601240278206012402 | 1 TUBE in 1 BOX (78206-124-02) / 50 g in 1 TUBEMarketed from Jun 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Diprolene
- Generic name (nonproprietary)
- betamethasone dipropionate
- Active ingredients
- Betamethasone dipropionate — .5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018741
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 78206-124_35f40d2c-b958-4c7a-88b1-47b1790996eeSPL ID 35f40d2c-b958-4c7a-88b1-47b1790996eeSPL set ID 0b9543ad-2ca7-430d-aef9-81c376dc2e6cRxCUI 848180, 848200UNII 826Y60901UUPC 0378206124012
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N478206012401followed by a unit qualifier and the quantityPackage 78206-0124-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
DIPROLENE ® Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. DIPROLENE Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 78206-124
- What is NDC 78206-124?
- 78206-124 is the product NDC for Diprolene (betamethasone dipropionate), Betamethasone dipropionate .5 mg/g ointment, listed with the FDA by Organon LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diprolene (Betamethasone dipropionate).
- What is the active ingredient?
- Betamethasone dipropionate.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diprolene?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 018741
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | OintmentTopical | Prasco Laboratories | 66993-897 |