What is NDC 45802-038?

45802-038 is the product NDC for erythromycin, Erythromycin 20 mg/mL solution, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

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 erythromycin?

68 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

erythromycin NDC 45802-038 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-038Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0038Add 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
45802-038-46	4580200384645802003846	1 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLEMarketed from Dec 19, 2011

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): erythromycin
Generic name (nonproprietary): erythromycin
Active ingredients: Erythromycin — 20 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 063038
Marketing start: Dec 19, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
Identifiers: Product ID 45802-038_81c83ddb-5432-484c-8a60-e51677a62c6bSPL ID 81c83ddb-5432-484c-8a60-e51677a62c6bSPL set ID 40edf1bd-42bb-4662-aff6-01fcc133c05dRxCUI 318202UNII 63937KV33D
Pharmacologic class: Macrolide Antimicrobial; Macrolide

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

N445802003846 followed by a unit qualifier and the quantity

Package 45802-0038-46. 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 27, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Erythromycin Topical Solution USP, 2% is indicated for the topical treatment of acne vulgaris.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-038

What is NDC 45802-038?: 45802-038 is the product NDC for erythromycin, Erythromycin 20 mg/mL solution, 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?: erythromycin.
What is the active ingredient?: Erythromycin.
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 erythromycin?: 68 other product NDCs are listed under this name. See all erythromycin 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 erythromycin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Erythromycin	Erythromycin 5 mg/g	OintmentOphthalmic	Sentiss Pharmaceuticals LLC	70244-031	70244-0031-0170244-0031-02
Erythromycin	Erythromycin 333 mg/1	Tablet, Delayed releaseOral	Torrent Pharmaceuticals Limited	13668-587	13668-0587-0113668-0587-0513668-0587-30
erythromycin	Erythromycin 250 mg/1	Capsule, Delayed release pelletsOral	Dr. Reddy's Labratories Inc.	75907-076	75907-0076-01
Erythromycin	Erythromycin 5 mg/g	OintmentOphthalmic	ST. MARY'S MEDICAL PARK PHARMACY	60760-670	60760-0670-35
Erythromycin	Erythromycin 5 mg/g	OintmentOphthalmic	Redpharm Drug	67296-2128	67296-2128-03
Erythromycin	Erythromycin 5 mg/g	OintmentOphthalmic	NuCare Pharmaceuticals,Inc.	68071-3992	68071-3992-02
Erythromycin	Erythromycin 5 mg/g	OintmentOphthalmic	ARMAS PHARMACEUTICALS INC.	72485-670	72485-0670-3172485-0670-35
Erythromycin	Erythromycin 5 mg/g	OintmentOphthalmic	Fera Pharmaceuticals, LLC	48102-057	48102-0057-11
Erythromycin	Erythromycin 250 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-397	46708-0397-3046708-0397-3146708-0397-91
Erythromycin	Erythromycin 500 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-398	46708-0398-3046708-0398-3146708-0398-91

All 69 erythromycin NDCs

Other NDCs under ANDA 063038

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

FDA NDC Directory listings under ANDA 063038
Product	Strength	Form · route	Labeler	Product NDC
erythromycin	Erythromycin 20 mg/mL	SolutionTopical	NuCare Pharmaceuticals,Inc.	68071-4791
erythromycin	Erythromycin 20 mg/mL	SolutionTopical	Bryant Ranch Prepack	72162-2075