What is NDC 45802-144?

45802-144 is the product NDC for hydrocortisone acetate pramoxine hcl, Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocortisone acetate, Pramoxine hydrochloride.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for hydrocortisone acetate pramoxine hcl?

16 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

hydrocortisone acetate pramoxine hcl NDC 45802-144

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-144Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0144Add 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
45802-144-64	4580201446445802014464	1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBEMarketed from Apr 13, 2010

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): hydrocortisone acetate pramoxine hcl
Generic name (nonproprietary): hydrocortisone acetate pramoxine hcl
Active ingredients: Hydrocortisone acetate — 1 g/100gPramoxine hydrochloride — 1 g/100g
Dosage form: Cream
Route: Topical
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 085368
Marketing start: Apr 13, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 45802-144_d2d16487-bf77-4da4-8fa8-3cf8dd1b98b3SPL ID d2d16487-bf77-4da4-8fa8-3cf8dd1b98b3SPL set ID 9eea5875-d153-4bba-aee2-b1d1cd8b5e57RxCUI 1235049UNII 3X7931PO74, 88AYB867L5
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

N445802014464 followed by a unit qualifier and the quantity

Package 45802-0144-64. 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 May 31, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Topical corticosteroids are 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 45802-144

What is NDC 45802-144?: 45802-144 is the product NDC for hydrocortisone acetate pramoxine hcl, Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: hydrocortisone acetate pramoxine hcl.
What is the active ingredient?: Hydrocortisone acetate, Pramoxine hydrochloride.
Who is the labeler?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for hydrocortisone acetate pramoxine hcl?: 16 other product NDCs are listed under this name. See all hydrocortisone acetate pramoxine hcl 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 hydrocortisone acetate pramoxine hcl NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
hydrocortisone acetate pramoxine HClhydrocortisone acetate, pramoxine hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	TRUPHARMA, LLC	52817-817	52817-0817-01
hydrocortisone acetate pramoxine HClhydrocortisone acetate, pramoxine hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Padagis Israel Pharmaceuticals Ltd	45802-124	45802-0124-1645802-0124-64
hydrocortisone acetate pramoxine HClhydrocortisone acetate, pramoxine hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	63629-8673	63629-8673-01
hydrocortisone acetate pramoxine HClhydrocortisone acetate, pramoxine hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	63629-8674	63629-8674-01
hydrocortisone acetate pramoxine HClhydrocortisone acetate, pramoxine hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	71335-2934	71335-2934-01
hydrocortisone acetate pramoxine HClhydrocortisone acetate, pramoxine hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	72162-1394	72162-1394-0272162-1394-04
hydrocortisone acetate pramoxine hcl	Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	63629-8669	63629-8669-01
hydrocortisone acetate pramoxine hcl	Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	72162-1399	72162-1399-03
Hydrocortisone Acetate Pramoxine Hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Padagis Israel Pharmaceuticals Ltd	45802-472	45802-0472-5345802-0472-6445802-0472-65
Hydrocortisone Acetate Pramoxine Hcl	Hydrocortisone acetate 2.5 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	63629-8670	63629-8670-01

All 17 hydrocortisone acetate pramoxine hcl NDCs

Other NDCs under ANDA 085368

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

FDA NDC Directory listings under ANDA 085368
Product	Strength	Form · route	Labeler	Product NDC
Analpram HChydrocortisone acetate and pramoxine hydrochloride	Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g	CreamTopical	Legacy Pharma USA Inc.	83107-018
hydrocortisone acetate pramoxine hcl	Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	63629-8669
hydrocortisone acetate pramoxine hcl	Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	72162-1399
Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride	Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g	CreamTopical	Legacy Pharma USA Inc.	83107-016
Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride	Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g	CreamTopical	Legacy Pharma USA Inc.	83107-017