NDC codes

FDA NDC Directory
Product NDC (as listed)0472-1738Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00472-1738Add 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
0472-1738-0300472173803004721738033 SUPPOSITORY in 1 CARTON (0472-1738-03)Marketed from Jan 18, 1995

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)
Miconazole Nitrate
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 200 mg/1
Dosage form
Suppository
Route
Vaginal
Labeler
Actavis Pharma, Inc.NDC labeler code 0472
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 073508
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 0472-1738_bb1aad58-4ca7-4be9-8649-0f29e22b81f5SPL ID bb1aad58-4ca7-4be9-8649-0f29e22b81f5SPL set ID aa9e250b-f317-42cb-b8d2-e85de56f4ef7RxCUI 992765UNII 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

N400472173803 followed by a unit qualifier and the quantity

Package 00472-1738-03. 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 Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0472-1738

What is NDC 0472-1738?
0472-1738 is the product NDC for Miconazole Nitrate, Miconazole nitrate 200 mg/1 suppository, 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?
Miconazole Nitrate.
What is the active ingredient?
Miconazole nitrate.
Who is the labeler?
Actavis Pharma, Inc., NDC labeler code 0472. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Miconazole Nitrate?
43 other product NDCs are listed under this name. See all Miconazole Nitrate 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 Miconazole Nitrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Miconazole Nitrateantifungal powder sprayMiconazole nitrate 20 mg/gAerosol, PowderTopicalPremier Brands of America Inc.56104-90756104-0907-01
Miconazole nitrateantifungal miconazole liquid continuous sprayMiconazole nitrate 20 mg/gAerosol, SprayTopicalPremier Brands of America Inc.56104-90356104-0903-01
Miconazole Nitrateanti-fungal powder miconazole nitrate talc freeMiconazole nitrate 20 mg/gPowderTopicalDiscount Drug Mart, Inc53943-97653943-0976-01
Miconazole Nitrateanti-fungal powder miconazole nitrate talc freeMiconazole nitrate 20 mg/gPowderTopicalHudson Health LLC72446-01472446-0014-01
Miconazole Nitrateathletes foot powder spray talc freeMiconazole nitrate 20 mg/gAerosol, PowderTopicalChain Drug Marketing Association83324-23383324-0233-46
Miconazole NitrateMiconazole nitrate 20 mg/gOintmentTopicalALLIED TRADE LINK LLC84387-00384387-0003-01
Miconazole NitrateMiconazole nitrate 2 g/100gPowderTopicalAvKARE42291-93842291-0938-85
Miconazole NitrateMiconazole nitrate 20 mg/gCreamTopicalSTRATEGIC SOURCING SERVICES LLC70677-100070677-1000-01
miconazole nitrateMiconazole nitrate 20 mg/mLSolutionTopicalAvPAK50268-50350268-0503-29
Miconazole Nitrateantifungal miconazole powder sprayMiconazole nitrate 2.6 g/130gAerosol, SprayTopicalPremier Brands of America Inc.56104-12156104-0121-01

All 44 Miconazole Nitrate NDCs

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