NDC codes

FDA NDC Directory
Product NDC (as listed)11673-391Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11673-0391Add 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
11673-391-06116730391061 TUBE, WITH APPLICATOR in 1 CARTON (11673-391-06) / 25 g in 1 TUBE, WITH APPLICATORMarketed from Oct 14, 2020

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)
Miconazole 3
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 40 mg/g
Dosage form
Cream
Route
Vaginal
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076773
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 11673-391_3a38916c-83b0-dad7-e063-6394a90a8f69SPL ID 3a38916c-83b0-dad7-e063-6394a90a8f69SPL set ID 12a2e441-4fdf-4c5e-b033-ba05ef12fc2fRxCUI 998544UNII VW4H1CYW1K
Pharmacologic class
Azole Antifungal

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N411673039106 followed by a unit qualifier and the quantity

Package 11673-0391-06. 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)

Use treats vaginal yeast infections

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076773

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

FDA NDC Directory listings under ANDA 076773
ProductStrengthForm · routeLabelerProduct NDC
Miconazole NitrateMiconazole nitrate 40 mg/gCreamVaginalSun Pharmaceutical Industries, Inc.51672-2070
Lagicam antifungalmiconazole nitrateMiconazole nitrate 40 mg/gCreamVaginalGenomma Lab USA, Inc.50066-070

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