NDC codes

FDA NDC Directory
Product NDC (as listed)63736-017Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63736-0017Add 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
63736-017-0363736001703637360017031 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBEMarketed from Apr 16, 1996

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)
Monistat 3
Generic name (nonproprietary)
miconazole nitrate
Dosage form
Kit
Labeler
Insight Pharmaceuticals LLCNDC labeler code 63736
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020670
Marketing start
Listing expires
Identifiers
Product ID 63736-017_5c3d76c4-7f00-29fe-e063-6294a90a1167SPL ID 5c3d76c4-7f00-29fe-e063-6294a90a1167

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

N463736001703 followed by a unit qualifier and the quantity

Package 63736-0017-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 63736-017

What is NDC 63736-017?
63736-017 is the product NDC for Monistat 3 (miconazole nitrate) kit, listed with the FDA by Insight Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Monistat 3 (Miconazole Nitrate).
Who is the labeler?
Insight Pharmaceuticals LLC, NDC labeler code 63736. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Monistat 3?
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 020670

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

FDA NDC Directory listings under NDA 020670
ProductStrengthForm · routeLabelerProduct NDC
Miconazole 1 Combination Packmiconazole nitrate—KitCVS PHARMACY, INC51316-005
Miconazole 3 Walgreen Companymiconazole nitrate—KitVaginalWALGREEN COMPANY0363-5203
Monistat 3 Combination Pack 3 Ovule Insertsmiconazole nitrate—KitInsight Pharmaceuticals LLC63736-019

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