Prescription drug · ANDA
Fluocinolone Acetonide Oil (Fluocinolone acetonide) NDC 64980-331
Fluocinolone acetonide .11 mg/mL · Oil · Topical · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-331-04 | 6498003310464980033104 | 118.28 mL in 1 BOTTLE (64980-331-04)Marketed from Jul 18, 2016 |
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)
- Fluocinolone Acetonide OilSuffix: Oil
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .11 mg/mL
- Dosage form
- Oil
- Route
- Topical
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203377
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 64980-331_f6254856-0b86-4d8d-9e92-66663f9f4d61SPL ID f6254856-0b86-4d8d-9e92-66663f9f4d61SPL set ID f45b0ef2-1702-4d21-8ac8-774769304595RxCUI 1191307UNII 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
N464980033104followed by a unit qualifier and the quantityPackage 64980-0331-04. 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)
Fluocinolone Acetonide Topical Oil, 0.01% is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients ( 1.1 ) topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: Apply the least amount to cover affected areas. Discontinue when disease is controlled. ( 1.3 ) Do not use in the diaper area. ( 1.3 ) Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 ) 1.1 Adult Patients with Atopic Dermatitis Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. 1.2 Pediatric Patients with Atopic Dermatitis Flu…
Excerpt only. Read the full label for complete information.
About NDC 64980-331
- What is NDC 64980-331?
- 64980-331 is the product NDC for Fluocinolone Acetonide Oil (fluocinolone acetonide), Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluocinolone Acetonide Oil (Fluocinolone Acetonide).
- What is the active ingredient?
- Fluocinolone acetonide.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 Oil?
- 3 other product NDCs are listed under this name. See all Fluocinolone Acetonide Oil 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 Oil 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 Oilfluocinolone acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Rising Pharma Holdings, Inc. | 64980-329 | 64980-0329-20 |
| Fluocinolone Acetonide Oilfluocinolone acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | A-S Medication Solutions | 50090-6780 | 50090-6780-00 |
| FLUOCINOLONE ACETONIDE Oilfluocinolone acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | RISING PHARMA HOLDINGS, INC. | 64980-330 | 64980-0330-04 |