NDC codes

FDA NDC Directory
Product NDC (as listed)0187-5202Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-5202Add 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
0187-5202-60001875202601 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBEMarketed from Sep 8, 2013

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)
Noritate
Generic name (nonproprietary)
metronidazole
Active ingredients
Metronidazole — 10 mg/60g
Dosage form
Cream
Route
Topical
Labeler
Bausch Health US, LLCNDC labeler code 0187
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020743
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 0187-5202_453f532e-bb72-4ea7-b9e5-b9ac903ffafeSPL ID 453f532e-bb72-4ea7-b9e5-b9ac903ffafeSPL set ID 706b09da-6cf9-421d-8e91-f3999474d322RxCUI 213120, 311680UNII 140QMO216E
Pharmacologic class
Nitroimidazole Antimicrobial

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

N400187520260 followed by a unit qualifier and the quantity

Package 00187-5202-60. 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)

INDICATIONS AND USAGE Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0187-5202

What is NDC 0187-5202?
0187-5202 is the product NDC for Noritate (metronidazole), Metronidazole 10 mg/60g cream, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Noritate (Metronidazole).
What is the active ingredient?
Metronidazole.
Who is the labeler?
Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Noritate?
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 020743

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

FDA NDC Directory listings under NDA 020743
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 10 mg/60gCreamTopicalOceanside Pharmaceuticals68682-202

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