What is NDC 43386-069?

43386-069 is the product NDC for Fluocinolone Acetonide, Fluocinolone acetonide .1 mg/mL solution, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluocinolone Acetonide NDC 43386-069

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-069Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0069Add 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
43386-069-60	4338600696043386006960	1 BOTTLE in 1 CARTON (43386-069-60) / 60 mL in 1 BOTTLEMarketed from Sep 2, 2015

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 — .1 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206422
Marketing start: Sep 2, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 43386-069_15764733-88e0-40bf-ac92-ff4e3e35b15dSPL ID 15764733-88e0-40bf-ac92-ff4e3e35b15dSPL set ID 460f5a55-6437-4651-bc08-8063ca579c8dRxCUI 1191310UNII 0CD5FD6S2MUPC 0343386069606
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

N443386006960 followed by a unit qualifier and the quantity

Package 43386-0069-60. 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 Feb 21, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluocinolone Acetonide Topical Solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-069

What is NDC 43386-069?: 43386-069 is the product NDC for Fluocinolone Acetonide, Fluocinolone acetonide .1 mg/mL solution, listed with the FDA by Lupin Pharmaceuticals,Inc.. 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?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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
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

All 32 Fluocinolone Acetonide NDCs