NDC codes

FDA NDC Directory
Product NDC (as listed)70752-159Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70752-0159Add 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
70752-159-2070752015920707520159201 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLEMarketed from Apr 2, 2021

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
Generic name (nonproprietary)
fluocinolone acetonide
Active ingredients
Fluocinolone acetonide — .11 mg/mL
Dosage form
Oil
Route
Auricular (Otic)
Labeler
Quagen Pharmaceuticals LLCNDC labeler code 70752
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212762
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 70752-159_c2b257ee-da2e-4af6-908a-aeb4838e698eSPL ID c2b257ee-da2e-4af6-908a-aeb4838e698eSPL set ID 2bcea813-d629-42c5-8953-fa231b4cbf58RxCUI 1191299UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N470752015920 followed by a unit qualifier and the quantity

Package 70752-0159-20. 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)

INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70752-159

What is NDC 70752-159?
70752-159 is the product NDC for Fluocinolone Acetonide, Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Quagen Pharmaceuticals LLC. It has 1 package NDC, 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?
Quagen Pharmaceuticals LLC, NDC labeler code 70752. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluocinolone Acetonide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
fluocinolone acetonideFluocinolone acetonide .1 mg/gCreamTopicalANI Pharmaceuticals, Inc.62559-28862559-0288-1562559-0288-60
fluocinolone acetonideFluocinolone acetonide .25 mg/gCreamTopicalANI Pharmaceuticals, Inc.62559-28962559-0289-1562559-0289-60
Fluocinolone AcetonideFluocinolone acetonide .25 mg/gOintmentTopicalANI Pharmaceuticals, Inc.62559-29962559-0299-1562559-0299-60
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilTopicalQuagen Pharmaceuticals LLC70752-15670752-0156-06
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilTopicalQuagen Pharmaceuticals LLC70752-15870752-0158-06
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilAuricular (Otic)Bryant Ranch Prepack71335-287971335-2879-01
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilTopicalBryant Ranch Prepack71335-288371335-2883-01
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilTopicalBryant Ranch Prepack71335-288471335-2884-01
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilTopicalBryant Ranch Prepack72162-231972162-2319-02
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilAuricular (Otic)Bryant Ranch Prepack72162-232072162-2320-02

All 32 Fluocinolone Acetonide NDCs

Other NDCs under ANDA 212762

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

FDA NDC Directory listings under ANDA 212762
ProductStrengthForm · routeLabelerProduct NDC
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilAuricular (Otic)Bryant Ranch Prepack71335-2879
Fluocinolone AcetonideFluocinolone acetonide .11 mg/mLOilAuricular (Otic)Bryant Ranch Prepack72162-2320

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