fluocinolone acetonide NDC 63629-8655

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8655Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8655Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63629-8655-1	63629865501	1 BOTTLE in 1 CARTON (63629-8655-1) / 118.28 mL in 1 BOTTLEMarketed from Jun 14, 2017

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): fluocinolone acetonide
Generic name (nonproprietary): fluocinolone acetonide
Active ingredients: Fluocinolone acetonide — .01 mg/100mL
Dosage form: Oil
Route: Topical
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202847
Marketing start: Jun 14, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 63629-8655_d426f300-cd7e-4356-9d1c-8738ceb1fba9SPL ID d426f300-cd7e-4356-9d1c-8738ceb1fba9SPL set ID 71541422-f12c-4e92-8012-dba59112070cUNII 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

N463629865501 followed by a unit qualifier and the quantity

Package 63629-8655-01. 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 Apr 12, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202847

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202847
Product	Strength	Form · route	Labeler	Product NDC
fluocinolone acetonide	Fluocinolone acetonide .01 mg/100mL	OilTopical	Padagis Israel Pharmaceuticals Ltd	45802-887
fluocinolone acetonide	Fluocinolone acetonide .01 mg/100mL	OilTopical	Bryant Ranch Prepack	72162-1434