What is NDC 68308-701?

68308-701 is the product NDC for Ivermectin, Ivermectin 10 mg/g cream, listed with the FDA by Mayne Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mayne Pharma Inc., NDC labeler code 68308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ivermectin?

28 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ivermectin NDC 68308-701 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68308-701Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68308-0701Add 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
68308-701-45	6830807014568308070145	1 TUBE in 1 CARTON (68308-701-45) / 45 g in 1 TUBEMarketed from Jan 8, 2024

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): Ivermectin
Generic name (nonproprietary): ivermectin
Active ingredients: Ivermectin — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Mayne Pharma Inc.NDC labeler code 68308
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 206255
Marketing start: Jan 8, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 68308-701_180415ea-bcf7-49ef-92f4-41d58324d752SPL ID 180415ea-bcf7-49ef-92f4-41d58324d752SPL set ID 39fbf2b3-cd2f-4e04-99c4-ca4390fae2bdRxCUI 1598068UNII 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

N468308070145 followed by a unit qualifier and the quantity

Package 68308-0701-45. 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 29, 2023.

Indications (excerpt from the label)

Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin 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 68308-701

What is NDC 68308-701?: 68308-701 is the product NDC for Ivermectin, Ivermectin 10 mg/g cream, listed with the FDA by Mayne Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ivermectin.
What is the active ingredient?: Ivermectin.
Who is the labeler?: Mayne Pharma Inc., NDC labeler code 68308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ivermectin?: 28 other product NDCs are listed under this name. See all Ivermectin 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 Ivermectin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ivermectin	Ivermectin 5 mg/g	LotionTopical	Azurity Pharmaceuticals, Inc.	24338-119	24338-0119-45
Ivermectin	Ivermectin 5 mg/g	LotionTopical	YYBA Corp	73581-021	73581-0021-04
Ivermectin	Ivermectin 3 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-293	27241-0293-73
Ivermectin	Ivermectin 5 mg/g	LotionTopical	AmerisourceBergen	46122-827	46122-0827-36
Ivermectin	Ivermectin 3 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1731	70771-1731-03
Ivermectin	Ivermectin 3 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-223	72578-0223-83
Ivermectin	Ivermectin 5 mg/g	LotionTopical	CVS Pharmacy	51316-985	51316-0985-08
Ivermectin	Ivermectin 3 mg/1	TabletOral	Advagen Pharma Ltd	72888-206	72888-0206-0972888-0206-3072888-0206-66
Ivermectin	Ivermectin 6 mg/1	TabletOral	Advagen Pharma Ltd	72888-207	72888-0207-0972888-0207-3072888-0207-66
ivermectin	Ivermectin 3 mg/1	TabletOral	EPIC PHARMA LLC	42806-017	42806-0017-20

All 29 Ivermectin NDCs

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
Soolantraivermectin	Ivermectin 10 mg/g	CreamTopical	Galderma Laboratories, L.P.	0299-3823