Terconazole NDC 50090-1196

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-1196Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-1196Add 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 NDC	11-digit (billing)	Package	Copy
50090-1196-0	50090119600	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-1196-0) / 20 g in 1 TUBE, WITH APPLICATORMarketed from Nov 28, 2014

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): Terconazole
Generic name (nonproprietary): terconazole
Active ingredients: Terconazole — 8 mg/g
Dosage form: Cream
Route: Vaginal
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075953
Marketing start: Apr 6, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 50090-1196_f235c1c5-0e31-43a4-abec-f622945d799eSPL ID f235c1c5-0e31-43a4-abec-f622945d799eSPL set ID 1e32bf0d-2a93-44ac-ae28-8d34e10380c0RxCUI 313227UNII 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

N450090119600 followed by a unit qualifier and the quantity

Package 50090-1196-00. 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 Jan 3, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Terconazole vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 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)

Other NDCs under ANDA 075953

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

FDA NDC Directory listings under ANDA 075953
Product	Strength	Form · route	Labeler	Product NDC
Terconazole	Terconazole 8 mg/g	CreamVaginal	Sun Pharmaceutical Industries, Inc.	51672-1302
Terconazole	Terconazole 8 mg/g	CreamVaginal	NuCare Pharmaceuticals,Inc.	68071-1626