NDC codes

FDA NDC Directory
Product NDC (as listed)49035-199Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0199Add 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
49035-199-0049035019900490350199001 KIT in 1 CARTON (49035-199-00) * 1 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBEMarketed from Jun 9, 2010

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)
equate miconazole 1
Generic name (nonproprietary)
miconazole nitrate
Dosage form
Kit
Labeler
Wal-Mart Stores IncNDC labeler code 49035
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079114
Marketing start
Listing expires
Identifiers
Product ID 49035-199_7fb9dd1c-2bd0-492d-bbf3-d0c4d7102252SPL ID 7fb9dd1c-2bd0-492d-bbf3-d0c4d7102252SPL set ID 5c5b0486-9ec2-4e14-a35c-80da8e62c59eRxCUI 992774, 992775, 998483, 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

N449035019900 followed by a unit qualifier and the quantity

Package 49035-0199-00. 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 49035-199

What is NDC 49035-199?
49035-199 is the product NDC for equate miconazole 1 (miconazole nitrate) kit, listed with the FDA by Wal-Mart Stores Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
equate miconazole 1 (Miconazole nitrate).
Who is the labeler?
Wal-Mart Stores Inc, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for equate miconazole 1?
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 079114

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

FDA NDC Directory listings under ANDA 079114
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Miconazolemiconazole nitrate—KitAmazon.com Services LLC72288-199
careone miconazole 1miconazole nitrate—KitAmerican Sales Company41520-616
exchange select miconazole 1miconazole nitrate—KitArmy & Air Force Exchange Service55301-211
Foster And Thrive Miconazole 1miconazole nitrate—KitStrategic Sourcing Services LLC70677-1294
Good Neighbor Pharmacy Miconazole 1miconazole nitrate—KitAmerisource Bergen46122-577
Miconazole 1miconazole nitrate—KitSafeway21130-929
miconazole 1miconazole nitrate—KitKroger Company30142-199
miconazole 1miconazole nitrate—KitH E B37808-199
miconazole 1miconazole nitrate—KitMeijer Distribution Inc41250-199
miconazole 1 yeast infection reliefmiconazole nitrate—KitCVS Pharmacy59779-199
Signature Care Miconazole 1miconazole nitrate—KitSafeway21130-040
topcare miconazole 1miconazole nitrate—KitTopco Associates LLC36800-199
up and up miconazolemiconazole nitrate—KitTarget Corporation11673-199

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