NDC codes

FDA NDC Directory
Product NDC (as listed)51316-093Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0093Add 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
51316-093-0151316009301513160093011 KIT in 1 PACKAGE, COMBINATION (51316-093-01) * 1 SUPPOSITORY in 1 POUCH (51316-094-01) * 9 g in 1 TUBE (51316-095-01)Marketed from Jan 30, 2022

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)
Cvs Miconazole 1 Combination Pack
Generic name (nonproprietary)
miconazole nitrate
Dosage form
Kit
Labeler
CVS PHARMACY, INCNDC labeler code 51316
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021308
Marketing start
Listing expires
Identifiers
Product ID 51316-093_0a2c3afd-9556-4ab3-87bd-1720ffa32af5SPL ID 0a2c3afd-9556-4ab3-87bd-1720ffa32af5SPL set ID db40f672-62b4-4844-a2d3-7e8617c40ec9RxCUI 992774, 992775, 998540

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

N451316009301 followed by a unit qualifier and the quantity

Package 51316-0093-01. 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 51316-093

What is NDC 51316-093?
51316-093 is the product NDC for Cvs Miconazole 1 Combination Pack kit, listed with the FDA by CVS PHARMACY, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cvs Miconazole 1 Combination Pack (Miconazole Nitrate).
Who is the labeler?
CVS PHARMACY, INC, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cvs Miconazole 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
Miconazole 1 Walgreensmiconazole nitrate—KitWALGREEN COMPANY0363-5201
Miconazole 1 Walgreensmiconazole nitrate—KitWALGREEN COMPANY0363-5211
Monistat 1 Combination Packmiconazole nitrate—KitInsight Pharmaceuticals LLC63736-013

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