Prescription drug · ANDA
Flurandrenolide NDC 72162-1439
Flurandrenolide .5 mg/mL · Lotion · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1439-2 | 72162143902 | 120 mL in 1 BOTTLE (72162-1439-2)Marketed from Aug 17, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Flurandrenolide
- Generic name (nonproprietary)
- flurandrenolide
- Active ingredients
- Flurandrenolide — .5 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207133
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72162-1439_f3f324b5-23ff-4171-b94f-db557655691bSPL ID f3f324b5-23ff-4171-b94f-db557655691bSPL set ID 2718df54-7dc1-4ebc-8258-607bedcf5813RxCUI 197719UNII 8EUL29XUQT
- 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
N472162143902followed by a unit qualifier and the quantityPackage 72162-1439-02. 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)
INDICATIONS AND USAGE Flurandrenolide Lotion USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
About NDC 72162-1439
- What is NDC 72162-1439?
- 72162-1439 is the product NDC for Flurandrenolide, Flurandrenolide .5 mg/mL lotion, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flurandrenolide.
- What is the active ingredient?
- Flurandrenolide.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 72162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Flurandrenolide?
- 2 other product NDCs are listed under this name. See all Flurandrenolide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flurandrenolide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flurandrenolide | Flurandrenolide .5 mg/mL | LotionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-928 | 45802-0928-03 |
| Flurandrenolide | Flurandrenolide .5 mg/mL | LotionTopical | Bryant Ranch Prepack | 63629-8657 | 63629-8657-01 |
Other NDCs under ANDA 207133
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 |
|---|---|---|---|---|
| Flurandrenolide | Flurandrenolide .5 mg/mL | LotionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-928 |
| Flurandrenolide | Flurandrenolide .5 mg/mL | LotionTopical | Bryant Ranch Prepack | 63629-8657 |