NDC codes

FDA NDC Directory
Product NDC (as listed)0713-0552Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00713-0552Add 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
0713-0552-73007130552733 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Sep 25, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Terconazole
Generic name (nonproprietary)
terconazole
Active ingredients
Terconazole — 80 mg/1
Dosage form
Suppository
Route
Vaginal
Labeler
Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077553
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 0713-0552_513edef8-abb4-1947-e063-6394a90af7bfSPL ID 513edef8-abb4-1947-e063-6394a90af7bfSPL set ID 38cd1718-6b3c-415d-a17f-7b399adb0ba2RxCUI 198245UNII 0KJ2VE664U
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

N400713055273 followed by a unit qualifier and the quantity

Package 00713-0552-73. 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)

INDICATIONS AND USAGE Terconazole Vaginal Suppositories, 80 mg is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0552

What is NDC 0713-0552?
0713-0552 is the product NDC for Terconazole, Terconazole 80 mg/1 suppository, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Terconazole.
What is the active ingredient?
Terconazole.
Who is the labeler?
Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Terconazole?
9 other product NDCs are listed under this name. See all Terconazole 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 Terconazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TerconazoleTerconazole 80 mg/1SuppositoryVaginalSun Pharmaceutical Industries, Inc.51672-133051672-1330-03
TerconazoleTerconazole 80 mg/1SuppositoryVaginalPadagis Israel Pharmaceuticals Ltd45802-71745802-0717-08
TerconazoleTerconazole 4 mg/gCreamVaginalA-S Medication Solutions50090-626650090-6266-00
TerconazoleTerconazole 4 mg/gCreamVaginalE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0168-034600168-0346-46
TerconazoleTerconazole 4 mg/gCreamVaginalA-S Medication Solutions50090-091750090-0917-00
TerconazoleTerconazole 4 mg/gCreamVaginalSun Pharmaceutical Industries, Inc.51672-130451672-1304-06
TerconazoleTerconazole 8 mg/gCreamVaginalA-S Medication Solutions50090-119650090-1196-00
TerconazoleTerconazole 8 mg/gCreamVaginalNuCare Pharmaceuticals,Inc.68071-162668071-1626-02
TerconazoleTerconazole 8 mg/gCreamVaginalSun Pharmaceutical Industries, Inc.51672-130251672-1302-00

Other NDCs under ANDA 077553

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

FDA NDC Directory listings under ANDA 077553
ProductStrengthForm · routeLabelerProduct NDC
TerconazoleTerconazole 80 mg/1SuppositoryVaginalSun Pharmaceutical Industries, Inc.51672-1330

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