NDC codes

FDA NDC Directory
Product NDC (as listed)63736-013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63736-0013Add 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
63736-013-3063736001330637360013301 KIT in 1 PACKAGE, COMBINATION (63736-013-30) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBEMarketed from Jun 29, 2001

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 1 Combination Pack
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 021308
Marketing start
Listing expires
Identifiers
Product ID 63736-013_50061b4b-e817-4ed7-8f2f-be4a17baf152SPL ID 50061b4b-e817-4ed7-8f2f-be4a17baf152SPL set ID 97ff1c90-c250-4921-81af-6a56cc9cc7d2RxCUI 992774, 992775, 992777, 992778, 998540, 998541

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

N463736001330 followed by a unit qualifier and the quantity

Package 63736-0013-30. 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)

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63736-013

What is NDC 63736-013?
63736-013 is the product NDC for Monistat 1 Combination Pack (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 1 Combination Pack (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 1 Combination Pack?
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 021308

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

FDA NDC Directory listings under NDA 021308
ProductStrengthForm · routeLabelerProduct NDC
Cvs Miconazole 1 Combination Packmiconazole nitrate—KitCVS PHARMACY, INC51316-093
Miconazole 1 Walgreensmiconazole nitrate—KitWALGREEN COMPANY0363-5201
Miconazole 1 Walgreensmiconazole nitrate—KitWALGREEN COMPANY0363-5211

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