Prescription drug · ANDA
Fluocinonide NDC 70771-1393
Fluocinonide 1 mg/g · Cream · Topical · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1393-2 | 7077113930270771139302 | 30 g in 1 TUBE (70771-1393-2)Marketed from Apr 30, 2020 | |
| 70771-1393-3 | 7077113930370771139303 | 60 g in 1 TUBE (70771-1393-3)Marketed from Apr 30, 2020 | |
| 70771-1393-5 | 7077113930570771139305 | 120 g in 1 TUBE (70771-1393-5)Marketed from Apr 30, 2020 |
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)
- Fluocinonide
- Generic name (nonproprietary)
- fluocinonide
- Active ingredients
- Fluocinonide — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208989
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70771-1393_785b93c3-9489-4d35-9dc5-5f64d5c604eeSPL ID 785b93c3-9489-4d35-9dc5-5f64d5c604eeSPL set ID 08d69d3f-c628-4b08-a7ae-0f7ec5599d3aRxCUI 485647UNII 2W4A77YPANUPC 0372578087067
- 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
N470771139302followed by a unit qualifier and the quantityPackage 70771-1393-02. 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 .
About NDC 70771-1393
- What is NDC 70771-1393?
- 70771-1393 is the product NDC for Fluocinonide, Fluocinonide 1 mg/g cream, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluocinonide.
- What is the active ingredient?
- Fluocinonide.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluocinonide?
- 50 other product NDCs are listed under this name. See all Fluocinonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluocinonide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | Saptalis Pharmaceuticals, LLC. | 71656-094 | 71656-0094-2071656-0094-60 |
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | NorthStar RxLLC | 72603-703 | 72603-0703-01 |
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | Bryant Ranch Prepack | 72162-2490 | 72162-2490-0272162-2490-06 |
| Fluocinonide | Fluocinonide .5 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-761 | 45802-0761-1545802-0761-3045802-0761-60 |
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | QUAGEN PHARMACEUTICALS LLC | 70752-154 | 70752-0154-05 |
| Fluocinonide | Fluocinonide .5 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-064 | 21922-0064-0321922-0064-0421922-0064-05+1 more |
| Fluocinonide | Fluocinonide .5 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8593 | 68788-8593-0368788-8593-06 |
| Fluocinonide | Fluocinonide .5 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-8554 | 68788-8554-06 |
| Fluocinonide | Fluocinonide .5 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0663 | 00713-0663-1500713-0663-3100713-0663-60 |
| Fluocinonide | Fluocinonide 1 mg/g | CreamTopical | Viona Pharmaceuticals Inc | 72578-087 | 72578-0087-0272578-0087-0672578-0087-07 |
Other NDCs under ANDA 208989
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 |
|---|---|---|---|---|
| Fluocinonide | Fluocinonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2508 |
| Fluocinonide | Fluocinonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2509 |
| Fluocinonide | Fluocinonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2510 |
| Fluocinonide | Fluocinonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2006 |
| Fluocinonide | Fluocinonide 1 mg/g | CreamTopical | Viona Pharmaceuticals Inc | 72578-087 |