What is NDC 0299-3823?

0299-3823 is the product NDC for Soolantra (ivermectin), Ivermectin 10 mg/g cream, listed with the FDA by Galderma Laboratories, L.P.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Galderma Laboratories, L.P., NDC labeler code 0299. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Soolantra?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Soolantra NDC 0299-3823 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0299-3823Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00299-3823Add 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
0299-3823-00	0029938230000299382300	2 g in 1 TUBE (0299-3823-00)Marketed from Nov 1, 2019 · Sample package
0299-3823-02	0029938230200299382302	1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBEMarketed from Jan 1, 2015 · Sample package
0299-3823-30	0029938233000299382330	1 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBEMarketed from Jan 1, 2015
0299-3823-45	0029938234500299382345	1 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBEMarketed from Jan 1, 2015
0299-3823-60	0029938236000299382360	1 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBEMarketed from Jan 1, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Soolantra
Generic name (nonproprietary): ivermectin
Active ingredients: Ivermectin — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Galderma Laboratories, L.P.NDC labeler code 0299
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206255
Marketing start: Jan 1, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4bSPL ID 253c7c90-5d85-b1e0-e063-6394a90a7a4bSPL set ID b1d5b166-ab06-4ab5-b0c6-31126238118aRxCUI 1598068, 1598073UNII 8883YP2R6D
Pharmacologic class: Antiparasitic; Pediculicide

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

N400299382300 followed by a unit qualifier and the quantity

Package 00299-3823-00. 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 Oct 24, 2024.

Indications (excerpt from the label)

SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea. SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0299-3823

What is NDC 0299-3823?: 0299-3823 is the product NDC for Soolantra (ivermectin), Ivermectin 10 mg/g cream, listed with the FDA by Galderma Laboratories, L.P.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Soolantra (Ivermectin).
What is the active ingredient?: Ivermectin.
Who is the labeler?: Galderma Laboratories, L.P., NDC labeler code 0299. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Soolantra?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 206255

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

FDA NDC Directory listings under NDA 206255
Product	Strength	Form · route	Labeler	Product NDC
Ivermectin	Ivermectin 10 mg/g	CreamTopical	Mayne Pharma Inc.	68308-701

Soolantra (Ivermectin) NDC 0299-3823