What is NDC 43386-096?

43386-096 is the product NDC for clobetasol propionate, Clobetasol propionate .5 mg/g ointment, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 4 package NDCs, 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 clobetasol propionate?

96 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

clobetasol propionate NDC 43386-096

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-096Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0096Add 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
43386-096-60	4338600966043386009660	1 TUBE in 1 CARTON (43386-096-60) / 15 g in 1 TUBEMarketed from Jun 2, 2018
43386-096-61	4338600966143386009661	1 TUBE in 1 CARTON (43386-096-61) / 30 g in 1 TUBEMarketed from Jun 2, 2018
43386-096-62	4338600966243386009662	1 TUBE in 1 CARTON (43386-096-62) / 60 g in 1 TUBEMarketed from Jun 2, 2018
43386-096-63	4338600966343386009663	1 TUBE in 1 CARTON (43386-096-63) / 45 g in 1 TUBEMarketed from Jun 2, 2018

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): clobetasol propionate
Generic name (nonproprietary): clobetasol propionate
Active ingredients: Clobetasol propionate — .5 mg/g
Dosage form: Ointment
Route: Topical
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208841
Marketing start: Jun 2, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 43386-096_370129be-84f5-4edf-b821-ffbad2db8c66SPL ID 370129be-84f5-4edf-b821-ffbad2db8c66SPL set ID 3e0fe7b1-f511-491f-b74d-3ca00449835bRxCUI 861448UNII 779619577MUPC 0343386096633, 0343386096626, 0343386096619
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

N443386009660 followed by a unit qualifier and the quantity

Package 43386-0096-60. 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 Aug 10, 2018.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clobetasol propionate ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-096

What is NDC 43386-096?: 43386-096 is the product NDC for clobetasol propionate, Clobetasol propionate .5 mg/g ointment, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: clobetasol propionate.
What is the active ingredient?: Clobetasol propionate.
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 clobetasol propionate?: 96 other product NDCs are listed under this name. See all clobetasol propionate 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 clobetasol propionate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	A-S Medication Solutions	50090-8001	50090-8001-00
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	NorthStar RxLLC	72603-855	72603-0855-0172603-0855-0272603-0855-03+1 more
Clobetasol Propionate	Clobetasol propionate .5 mg/g	Aerosol, FoamTopical	Alembic Pharmaceuticals Limited	46708-707	46708-0707-3146708-0707-50
Clobetasol Propionate	Clobetasol propionate .5 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-547	46708-0547-1546708-0547-3046708-0547-45+1 more
Clobetasol Propionate	Clobetasol propionate .05 g/100mL	ShampooTopical	Alembic Pharmaceuticals Limited	46708-548	46708-0548-04
Clobetasol Propionate	Clobetasol propionate .5 mg/mL	SolutionTopical	Alembic Pharmaceuticals Limited	46708-486	46708-0486-2546708-0486-50
Clobetasol Propionate	Clobetasol propionate .05 g/mL	SprayTopical	Alembic Pharmaceuticals Limited	46708-425	46708-0425-1246708-0425-59
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	Alembic Pharmaceuticals Limited	46708-465	46708-0465-1546708-0465-3046708-0465-45+1 more
Clobetasol Propionate	Clobetasol propionate .25 mg/g	CreamTopical	INA Pharmaceutics Inc	74157-710	74157-0710-10
Clobetasol Propionate	Clobetasol propionate .5 mg/g	CreamTopical	Torrent Pharmaceuticals Limited	13668-569	13668-0569-0113668-0569-0213668-0569-04+1 more

All 97 clobetasol propionate NDCs

Other NDCs under ANDA 208841

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

FDA NDC Directory listings under ANDA 208841
Product	Strength	Form · route	Labeler	Product NDC
clobetasol propionate	Clobetasol propionate .5 mg/g	OintmentTopical	Novel Laboratories, Inc.	40032-096