NDC codes

FDA NDC Directory
Product NDC (as listed)72162-1434Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-1434Add 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 NDC11-digit (billing)PackageCopy
72162-1434-2721621434021 BOTTLE in 1 CARTON (72162-1434-2) / 118.28 mL in 1 BOTTLEMarketed from Mar 12, 2024

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202847
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 72162-1434_c4b24e65-1fe8-47bf-ba99-b81afcbbf2d2SPL ID c4b24e65-1fe8-47bf-ba99-b81afcbbf2d2SPL set ID 4790bdfa-c964-4c3e-9d01-c2fb23a0172eUNII 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

N472162143402 followed by a unit qualifier and the quantity

Package 72162-1434-02. 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)

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 Derm…

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
ProductStrengthForm · routeLabelerProduct NDC
fluocinolone acetonideFluocinolone acetonide .01 mg/100mLOilTopicalPadagis Israel Pharmaceuticals Ltd45802-887
fluocinolone acetonideFluocinolone acetonide .01 mg/100mLOilTopicalBryant Ranch Prepack63629-8655

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