NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0669Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0669Add 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
70000-0669-170000066901700000669011 KIT in 1 CARTON (70000-0669-1) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBEMarketed from Jun 27, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Leader Miconazole 3
Generic name (nonproprietary)
miconazole nitrate
Dosage form
Kit
Labeler
Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076357
Marketing start
Listing expires
Identifiers
Product ID 70000-0669_1c6314df-4429-4d58-bdc2-12830d55f036SPL ID 1c6314df-4429-4d58-bdc2-12830d55f036SPL set ID 7f6df893-f404-4b2d-ab2b-696c8a2d36faRxCUI 992816, 998540, 998544

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

N470000066901 followed by a unit qualifier and the quantity

Package 70000-0669-01. 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 70000-0669

What is NDC 70000-0669?
70000-0669 is the product NDC for Leader Miconazole 3 (miconazole nitrate) kit, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader Miconazole 3 (Miconazole nitrate).
Who is the labeler?
Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leader Miconazole 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 ANDA 076357

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

FDA NDC Directory listings under ANDA 076357
ProductStrengthForm · routeLabelerProduct NDC
foster and thrive miconazole 3miconazole nitrate—KitStrategic Sourcing Services LLC70677-1223
Miconazole 3miconazole nitrate—KitRite Aid Corporation11822-0800
Miconazole 3miconazole nitrate—KitMeijer Distribution Inc41250-982
Miconazole 3miconazole nitrate—KitCVS Pharmacy59779-839
Rugby Miconazole 3miconazole nitrate—KitRugby Laboratories0536-1425
Up and Up Miconazole 3miconazole nitrate—KitTarget Corporation11673-982

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in