Prescription drug · ANDA
Betamethasone Dipropionate NDC 35573-107
Betamethasone dipropionate .5 mg/g · Ointment, Augmented · Topical · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-107-15 | 35573010715 | 1 TUBE in 1 CARTON (35573-107-15) / 15 g in 1 TUBEMarketed from Jan 15, 2025 | |
| 35573-107-49 | 35573010749 | 1 TUBE in 1 CARTON (35573-107-49) / 50 g in 1 TUBEMarketed from Jan 15, 2025 |
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)
- Betamethasone Dipropionate
- Generic name (nonproprietary)
- betamethasone dipropionate
- Active ingredients
- Betamethasone dipropionate — .5 mg/g
- Dosage form
- Ointment, Augmented
- Route
- Topical
- Labeler
- Burel Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218289
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 35573-107_c8bda9a8-4dec-4084-84e5-4b4623390bd8SPL ID c8bda9a8-4dec-4084-84e5-4b4623390bd8SPL set ID c8bda9a8-4dec-4084-84e5-4b4623390bd8RxCUI 848180UNII 826Y60901UUPC 0335573107154, 0335573107499
- 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
N435573010715followed by a unit qualifier and the quantityPackage 35573-0107-15. 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)
Betamethasone dipropionate ointment (augmented) 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. Betamethasone dipropionate ointment (augmented) 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.
Other NDCs under ANDA 218289
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 | Ointment, AugmentedTopical | Aurobindo Pharma Limited | 59651-699 |