NDC codes

FDA NDC Directory
Product NDC (as listed)0591-4052Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00591-4052Add 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 NDC11-digit (billing)PackageCopy
0591-4052-8900591405289005914052891 TUBE in 1 CARTON (0591-4052-89) / 45 g in 1 TUBEMarketed from Oct 14, 2019

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)
Ivermectin
Generic name (nonproprietary)
ivermectin
Active ingredients
Ivermectin — 10 mg/g
Dosage form
Cream
Route
Topical
Labeler
Actavis Pharma, Inc.NDC labeler code 0591
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210019
Marketing start
Listing expires
Identifiers
Product ID 0591-4052_14ca838b-d540-4653-ac10-261e77906a51SPL ID 14ca838b-d540-4653-ac10-261e77906a51SPL set ID de9253c3-7d66-47fe-8ad7-8c0d4ee8ebdaRxCUI 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

N400591405289 followed by a unit qualifier and the quantity

Package 00591-4052-89. 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 .

Indications (excerpt from the label)

Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin cream, 1% 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 0591-4052

What is NDC 0591-4052?
0591-4052 is the product NDC for Ivermectin, Ivermectin 10 mg/g cream, listed with the FDA by Actavis 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?
Actavis Pharma, Inc., NDC labeler code 0591. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IvermectinIvermectin 5 mg/gLotionTopicalAzurity Pharmaceuticals, Inc.24338-11924338-0119-45
IvermectinIvermectin 5 mg/gLotionTopicalYYBA Corp73581-02173581-0021-04
IvermectinIvermectin 3 mg/1TabletOralAjanta Pharma USA Inc.27241-29327241-0293-73
IvermectinIvermectin 5 mg/gLotionTopicalAmerisourceBergen46122-82746122-0827-36
IvermectinIvermectin 3 mg/1TabletOralZydus Lifesciences Limited70771-173170771-1731-03
IvermectinIvermectin 3 mg/1TabletOralViona Pharmaceuticals Inc72578-22372578-0223-83
IvermectinIvermectin 5 mg/gLotionTopicalCVS Pharmacy51316-98551316-0985-08
IvermectinIvermectin 3 mg/1TabletOralAdvagen Pharma Ltd72888-20672888-0206-0972888-0206-3072888-0206-66
IvermectinIvermectin 6 mg/1TabletOralAdvagen Pharma Ltd72888-20772888-0207-0972888-0207-3072888-0207-66
ivermectinIvermectin 3 mg/1TabletOralEPIC PHARMA LLC42806-01742806-0017-20

All 29 Ivermectin NDCs

Other NDCs under ANDA 210019

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

FDA NDC Directory listings under ANDA 210019
ProductStrengthForm · routeLabelerProduct NDC
IvermectinIvermectin 10 mg/gCreamTopicalBryant Ranch Prepack63629-8754

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