Prescription drug · ANDA
Fluocinolone Acetonide NDC 0713-0223
Fluocinolone acetonide .1 mg/g · Cream · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0223-15 | 0071302231500713022315 | 1 TUBE in 1 CARTON (0713-0223-15) / 15 g in 1 TUBEMarketed from Jul 26, 1988 | |
| 0713-0223-60 | 0071302236000713022360 | 1 TUBE in 1 CARTON (0713-0223-60) / 60 g in 1 TUBEMarketed from Jul 26, 1988 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Fluocinolone Acetonide
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089526
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0713-0223_0abbbbe6-b694-1260-e063-6294a90a6f81SPL ID 0abbbbe6-b694-1260-e063-6294a90a6f81SPL set ID de5b78ab-ff79-3e0f-cad4-ecab11ebbdcdRxCUI 1191256, 1191302, 1191315UNII 0CD5FD6S2M
- 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
N400713022315followed by a unit qualifier and the quantityPackage 00713-0223-15. 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)
INDICATIONS AND USAGE Topical corticosteroids are 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 0713-0223
- What is NDC 0713-0223?
- 0713-0223 is the product NDC for Fluocinolone Acetonide, Fluocinolone acetonide .1 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluocinolone Acetonide.
- What is the active ingredient?
- Fluocinolone acetonide.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluocinolone Acetonide?
- 31 other product NDCs are listed under this name. See all Fluocinolone Acetonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluocinolone Acetonide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| fluocinolone acetonide | Fluocinolone acetonide .1 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-288 | 62559-0288-1562559-0288-60 |
| fluocinolone acetonide | Fluocinolone acetonide .25 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-289 | 62559-0289-1562559-0289-60 |
| Fluocinolone Acetonide | Fluocinolone acetonide .25 mg/g | OintmentTopical | ANI Pharmaceuticals, Inc. | 62559-299 | 62559-0299-1562559-0299-60 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Quagen Pharmaceuticals LLC | 70752-156 | 70752-0156-06 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Quagen Pharmaceuticals LLC | 70752-158 | 70752-0158-06 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Quagen Pharmaceuticals LLC | 70752-159 | 70752-0159-20 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Bryant Ranch Prepack | 71335-2879 | 71335-2879-01 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Bryant Ranch Prepack | 71335-2883 | 71335-2883-01 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Bryant Ranch Prepack | 71335-2884 | 71335-2884-01 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Bryant Ranch Prepack | 72162-2319 | 72162-2319-02 |