Over-the-counter drug · ANDA

Tioconazole 1 (Tioconazole) NDC 37808-426

Tioconazole 6.5 g/100g · Ointment · Vaginal · H E B

NDC codes

FDA NDC Directory
Product NDC (as listed)37808-426Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0426Add 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
37808-426-5437808042654378080426541 POUCH in 1 CARTON (37808-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATORMarketed from May 9, 2016

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)
Tioconazole 1
Generic name (nonproprietary)
tioconazole
Active ingredients
Tioconazole — 6.5 g/100g
Dosage form
Ointment
Route
Vaginal
Labeler
H E BNDC labeler code 37808
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075915
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 37808-426_1a9e72ed-ef88-4ddb-b23b-007507cc3b15SPL ID 1a9e72ed-ef88-4ddb-b23b-007507cc3b15SPL set ID 8bd3f5e8-5a8f-4d6a-b257-c315eec66318RxCUI 198380UNII S57Y5X1117
Pharmacologic class
Azole Antifungal

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

N437808042654 followed by a unit qualifier and the quantity

Package 37808-0426-54. 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)

Use • treats vaginal yeast infections

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 37808-426

What is NDC 37808-426?
37808-426 is the product NDC for Tioconazole 1 (tioconazole), Tioconazole 6.5 g/100g ointment, listed with the FDA by H E B. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tioconazole 1 (Tioconazole).
What is the active ingredient?
Tioconazole.
Who is the labeler?
H E B, NDC labeler code 37808. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tioconazole 1?
5 other product NDCs are listed under this name. See all Tioconazole 1 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 Tioconazole 1 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalAmazon.com Services LLC72288-22272288-0222-54
Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalSafeway21130-78121130-0781-54
tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalCVS Pharmacy59779-71859779-0718-26
tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalMeijer Distribution Inc41250-42641250-0426-54
Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalWalgreen Company0363-042600363-0426-54

Other NDCs under ANDA 075915

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

FDA NDC Directory listings under ANDA 075915
ProductStrengthForm · routeLabelerProduct NDC
foster and thrive tioconazoletioconazoleTioconazole 6.5 g/100gOintmentVaginalStrategic Sourcing Services LLC70677-1224
signature care tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalSafeway21130-060
VagistattioconazoleTioconazole 6.5 g/100gOintmentVaginalCombe Incorporated11509-0426
Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalSafeway21130-781
tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalMeijer Distribution Inc41250-426
Up and up tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalTarget Corporation11673-426
basic care tioconazoletioconazoleTioconazole 6.5 g/100gOintmentVaginalAmazon.com Services LLC72288-426
Monistat Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentTopicalInsight Pharmaceuticals LLC63736-413
tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalCVS Pharmacy59779-718
good sense tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalL. Perrigo Company0113-0426
CareOne Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalAmerican Sales Company41520-426
Topcare Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalTopco Associates LLC36800-426
dg health tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalDolgencorp Inc55910-731
Equate tioconazole 1 daytioconazoleTioconazole 6.5 g/100gOintmentVaginalWal-Mart Stores Inc49035-426
Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalWalgreen Company0363-0426
Leader Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalCardinal Health 110, LLC. dba Leader70000-0357
Tioconazole 1tioconazoleTioconazole 6.5 g/100gOintmentVaginalAmazon.com Services LLC72288-222

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