NDC codes

FDA NDC Directory
Product NDC (as listed)68016-731Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68016-0731Add 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
68016-731-0468016073104680160731041 KIT in 1 PACKAGE, COMBINATION (68016-731-04) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBEMarketed from Sep 11, 2003

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 Combination Pack
Generic name (nonproprietary)
miconazole nitrate
Dosage form
Kit
Labeler
Chain Drug Consortium, LLCNDC labeler code 68016
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074926
Marketing start
Marketing end
Identifiers
Product ID 68016-731_0c7a9e1a-ac2f-4faa-afbf-b2d19287b897SPL ID 0c7a9e1a-ac2f-4faa-afbf-b2d19287b897SPL set ID d01f7ef9-4f04-4874-a625-0335f6392b73RxCUI 992765, 992766, 998540UPC 0840986011245

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

N468016073104 followed by a unit qualifier and the quantity

Package 68016-0731-04. 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 68016-731

What is NDC 68016-731?
68016-731 is the product NDC for Miconazole 3 Combination Pack (miconazole nitrate) kit, listed with the FDA by Chain Drug Consortium, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Miconazole 3 Combination Pack (Miconazole Nitrate).
Who is the labeler?
Chain Drug Consortium, LLC, NDC labeler code 68016. 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 3 Combination Pack?
2 other product NDCs are listed under this name. See all Miconazole 3 Combination Pack 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 3 Combination Pack NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Miconazole 3 Combination Packmiconazole nitrate—KitEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-34549035-0345-03
Miconazole 3 Combination Packmiconazole nitrate—KitCVS Pharmacy59779-77359779-0773-43

Other NDCs under ANDA 074926

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

FDA NDC Directory listings under ANDA 074926
ProductStrengthForm · routeLabelerProduct NDC
Miconazole 3 Combination Packmiconazole nitrate—KitEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-345
Miconazole 3 Combination Packmiconazole nitrate—KitCVS Pharmacy59779-773
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitmiconazole nitrate—KitCosette Pharmaceuticals, Inc.0713-0593

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